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| fda guidelines for technology transfer: ISPE Good Practice Guide Ispe, 2019-01-24 |
| fda guidelines for technology transfer: Guideline for Submitting Samples and Analytical Data for Methods Validation , 1987 |
| fda guidelines for technology transfer: Continuous Manufacturing for the Modernization of Pharmaceutical Production National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, 2019-04-05 On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop. |
| fda guidelines for technology transfer: Enabling America Institute of Medicine, Committee on Assessing Rehabilitation Science and Engineering, 1997-11-24 The most recent high-profile advocate for Americans with disabilities, actor Christopher Reeve, has highlighted for the public the economic and social costs of disability and the importance of rehabilitation. Enabling America is a major analysis of the field of rehabilitation science and engineering. The book explains how to achieve recognition for this evolving field of study, how to set priorities, and how to improve the organization and administration of the numerous federal research programs in this area. The committee introduces the enabling-disability process model, which enhances the concepts of disability and rehabilitation, and reviews what is known and what research priorities are emerging in the areas of: Pathology and impairment, including differences between children and adults. Functional limitationsâ€in a person's ability to eat or walk, for example. Disability as the interaction between a person's pathologies, impairments, and functional limitations and the surrounding physical and social environments. This landmark volume will be of special interest to anyone involved in rehabilitation science and engineering: federal policymakers, rehabilitation practitioners and administrators, researchers, and advocates for persons with disabilities. |
| fda guidelines for technology transfer: Handbook of Stability Testing in Pharmaceutical Development Kim Huynh-Ba, 2008-11-16 This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices. |
| fda guidelines for technology transfer: Medical Devices and the Public's Health Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process, 2011-11-25 Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework. |
| fda guidelines for technology transfer: Technology Transfer Systems in the United States and Germany Fraunhofer Institute for Systems and Innovation Research, National Academy of Engineering, 1997-10-10 This book explores major similarities and differences in the structure, conduct, and performance of the national technology transfer systems of Germany and the United States. It maps the technology transfer landscape in each country in detail, uses case studies to examine the dynamics of technology transfer in four major technology areas, and identifies areas and opportunities for further mutual learning between the two national systems. |
| fda guidelines for technology transfer: Modern Methods of Clinical Investigation Institute of Medicine, Committee on Technological Innovation in Medicine, 1990-02-01 The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians. |
| fda guidelines for technology transfer: Oversight and Review of Clinical Gene Transfer Protocols Institute of Medicine, Board on Health Sciences Policy, Committee on the Independent Review and Assessment of the Activities of the NIH Recombinant DNA Advisory Committee, 2014-03-27 Gene transfer research is a rapidly advancing field that involves the introduction of a genetic sequence into a human subject for research or diagnostic purposes. Clinical gene transfer trials are subject to regulation by the U.S. Food and Drug Administration (FDA) at the federal level and to oversight by institutional review boards (IRBs) and institutional biosafety committees (IBCs) at the local level before human subjects can be enrolled. In addition, at present all researchers and institutions funded by the National Institutes of Health (NIH) are required by NIH guidelines to submit human gene transfer protocols for advisory review by the NIH Recombinant DNA Advisory Committee (RAC). Some protocols are then selected for individual review and public discussion. Oversight and Review of Clinical Gene Transfer Protocols provides an assessment of the state of existing gene transfer science and the current regulatory and policy context under which research is investigated. This report assesses whether the current oversight of individual gene transfer protocols by the RAC continues to be necessary and offers recommendations concerning the criteria the NIH should employ to determine whether individual protocols should receive public review. The focus of this report is on the standards the RAC and NIH should use in exercising its oversight function. Oversight and Review of Clinical Gene Transfer Protocols will assist not only the RAC, but also research institutions and the general public with respect to utilizing and improving existing oversight processes. |
| fda guidelines for technology transfer: Guideline on General Principles of Process Validation , 1987 |
| fda guidelines for technology transfer: Drug Discovery and Evaluation: Methods in Clinical Pharmacology H.Gerhard Vogel, Jochen Maas, Alexander Gebauer, 2010-12-15 Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series Drug Discovery and Evaluation in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series Pharmacological Assays comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays. Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology. |
| fda guidelines for technology transfer: Hearing Health Care for Adults National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Accessible and Affordable Hearing Health Care for Adults, 2016-10-06 The loss of hearing - be it gradual or acute, mild or severe, present since birth or acquired in older age - can have significant effects on one's communication abilities, quality of life, social participation, and health. Despite this, many people with hearing loss do not seek or receive hearing health care. The reasons are numerous, complex, and often interconnected. For some, hearing health care is not affordable. For others, the appropriate services are difficult to access, or individuals do not know how or where to access them. Others may not want to deal with the stigma that they and society may associate with needing hearing health care and obtaining that care. Still others do not recognize they need hearing health care, as hearing loss is an invisible health condition that often worsens gradually over time. In the United States, an estimated 30 million individuals (12.7 percent of Americans ages 12 years or older) have hearing loss. Globally, hearing loss has been identified as the fifth leading cause of years lived with disability. Successful hearing health care enables individuals with hearing loss to have the freedom to communicate in their environments in ways that are culturally appropriate and that preserve their dignity and function. Hearing Health Care for Adults focuses on improving the accessibility and affordability of hearing health care for adults of all ages. This study examines the hearing health care system, with a focus on non-surgical technologies and services, and offers recommendations for improving access to, the affordability of, and the quality of hearing health care for adults of all ages. |
| fda guidelines for technology transfer: New Medical Devices Institute of Medicine, National Academy of Engineering, 1988-01-01 In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices. |
| fda guidelines for technology transfer: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-03-11 This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. |
| fda guidelines for technology transfer: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-04-04 With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. |
| fda guidelines for technology transfer: Blood Banking and Regulation Institute of Medicine, Forum on Blood Safety and Blood Availability, 1996-06-19 This volume examines regulatory and policymaking procedures in blood banking, regulatory enforcement and compliance, innovations and alternatives in regulation, congressional oversight and regulatory initiatives, and investment in regulatory quality. |
| fda guidelines for technology transfer: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition Anurag S. Rathore, Gail Sofer, 2012-05-09 Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations. |
| fda guidelines for technology transfer: Generic drug entry prior to patent expiration an FTC study , 2002 |
| fda guidelines for technology transfer: Registries for Evaluating Patient Outcomes Agency for Healthcare Research and Quality/AHRQ, 2014-04-01 This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. |
| fda guidelines for technology transfer: Regulatory Aspects of Gene Therapy and Cell Therapy Products Maria Cristina Galli, Mercedes Serabian, 2015-09-15 This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent must-know guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals. |
| fda guidelines for technology transfer: Phase Appropriate GMP for Biological Processes Trevor Deeks, 2018-04 |
| fda guidelines for technology transfer: Mitochondrial Replacement Techniques National Academies of Sciences, Engineering, and Medicine, Institute of Medicine, Board on Health Sciences Policy, Committee on the Ethical and Social Policy Considerations of Novel Techniques for Prevention of Maternal Transmission of Mitochondrial DNA Diseases, 2016-04-17 Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications. |
| fda guidelines for technology transfer: Pharmaceutical Process Scale-Up, Third Edition Michael Levin, 2011-02-02 The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization. |
| fda guidelines for technology transfer: Academic Entrepreneurship for Medical and Health Scientists Nalaka Gooneratne, Rachel McGarrigle, Flaura Winston, 2020-06 The recent momentum and urgency around translating science and technology into health innovation is inspiring. It is transforming academia, too, as the rapidly-evolving world of health innovation has given rise to a new breed of academic - the academic entrepreneur - who works to move ideas from initial research to practical implementation. The work of these individuals is crucial to realizing the potential of investments in better care, and yet there existed no central repository for information and wisdom relevant to their mission; no place to house and explore the evolving knowledge base around translating evidence into impact.We aim to build one. In the spirit of collaboration, the Children's Hospital of Philadelphia (CHOP) Research Institute collaborated with the University of Pennsylvania's (Penn) Institute for Translational Medicine and Therapeutics (ITMAT) to seed fund a grassroots effort of editors, subject matter experts, and translational research students to create a free open education resource stored on ScholarlyCommons (University of Pennsylvania, Philadelphia, PA).Academic Entrepreneurship seeks to build a diverse community of empowered professionals who know how to bridge the worlds of academic research and commercialization to turn ideas and discoveries into innovations that provide value to patients, providers, and healthcare systems, thereby realizing full market potential and societal impact. This book is a repository of tools, advice, and best practices that establishes a foundation for academic researchers and innovators wherever they may reside.Recognizing that academic entrepreneurs are busy and bright, and have limited time to learn entrepreneurship, the chapters in this book were designed as an efficient and state-of-the-art source of guidance. With carefully curated content as a strong foundation, the reader will have quick introductions to key topics in academic entrepreneurship and innovations with a list of resources for those who wish to go further.This book was created as a limited print run of the first edition of the living content stored in the University of Pennsylvania's open access repository, ScholarlyCommons, as of 1/1/2020. As a living e-textbook, the content of Academic Entrepreneurship for Medical and Health Scientists is continuously enhanced and revised. |
| fda guidelines for technology transfer: Scientific Principles of Adipose Stem Cells Lauren Kokai, Kacey Marra, J. Peter Rubin, 2021-08-19 Scientific Principles of Adipose Stem Cells provides readers with in-depth and expert knowledge on adipose stem cells, their developmental biologic origins, foundational research on ASC signaling mechanisms and immunomodulatory properties, and clinical insights into applications in regenerative medicine. Topics covered include basic adipose stem cell developmental biology and mechanisms of regulating self-renewal and activation in the stem cell niche, important methods for isolation and characterizing ASCs, and data on the impact on human demographics (age, sex, BMI) on ASC phenotype. A section devoted to ASC biology, ASCs for stem cell therapy and regenerative medicine, and ASCs in tissue engineering applications are also included. The book is written for scientists and clinicians who are broadly familiar with stem cells and basic cell biology principles and those seeking advanced information on adipose stem cells. - Coverage of basic adipose stem cell developmental biology (maturation process during embryogenesis) and mechanisms of regulating self-renewal and activation in the stem cell niche - Includes important methods for isolation and characterizing ASCs, as well as known data any impact of human demographics (age, sex, BMI) on ASC phenotype - An entire section dedicated to ASC biology, additional sections will be devoted to ASCs for stem cell therapy and regenerative medicine, as well as ASCs in tissue engineering applications |
| fda guidelines for technology transfer: Orphans and Incentives Institute of Medicine, Forum on Emerging Infections, 1997-10-30 Infectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues. |
| fda guidelines for technology transfer: Technology Transfer Stewart Green, Paul Warren, 2002-08-14 This text is written by two leading quality specialists and serves as a quick guide reviewing the basic concepts associated with the transfer of product development between manufacturing sites, often to different parts of the world where cultural and management differences abound. It is a hot topic which is brought down to earth, covering key activities, documentation, reporting, and post-transfer reporting for manufacturing professionals. |
| fda guidelines for technology transfer: Validation of Active Pharmaceutical Ingredients Ira R. Berry, Daniel Harpaz, 2001 Much has happened in the area of bulk pharmaceutical good manufacturing practice (GMP) and validation since the first publication of Validation of Active Pharmaceutical Ingredients. Revised, updated, and expanded, this second edition includes new chapters addressing postapproval changes, technology transfer, international cGMP guidelines/FDA guidance progress, and facility inspection issues. The basic philosophy and principles of GMP and validation have not changed, but new terminology had been introduced, and old terminology had been better defined, improving the understanding of related concepts and principles. The book gives you a working knowledge of the regulatory process that will facilitate your organization's compliance with regulations. |
| fda guidelines for technology transfer: In Vitro-In Vivo Correlations David B. Young, John G. Devane, Jackie Butler, 2013-03-08 This book represents the invited presentations and some of the posters presented at the conference entitled In Vitro-In Vivo Relationship (IVIVR) Workshop held in Sep tember, 1996. The workshop was organized by the IVIVR Cooperative Working Group which has drawn together scientists from a number of organizations and institutions, both academic and industrial. In addition to Elan Corporation, which is a drug delivery com pany specializing in the development of ER (Extended Release) dosage forms, the IVIVR Cooperative Working Group consists of collaborators from the University of Maryland at Baltimore, University College Dublin, Trinity College Dublin, and the University of Not tingham in the UK. The principal collaborators are: Dr. Jackie Butler, Elan Corporation Prof. Owen Corrigan, Trinity College Dublin Dr. lain Cumming, Elan Corporation Dr. John Devane, Elan Corporation Dr. Adrian Dunne, University College Dublin Dr. Stuart Madden, Elan Corporation Dr. Colin Melia, University of Nottingham Mr. Tom O'Hara, Elan Corporation Dr. Deborah Piscitelli, University of Maryland at Baltimore Dr. Araz Raoof, Elan Corporation Mr. Paul Stark, Elan Corporation Dr. David Young, University of Maryland at Baltimore The purpose of the workshop was to discuss new concepts and methods in the devel opment of in vitro-in vivo relationships for ER products. The original idea went back ap proximately 15 months prior to the workshop itself. For some time, the principal collaborators had been working together on various aspects of dosage form development. |
| fda guidelines for technology transfer: Generic Drug Product Development Leon Shargel, Isadore Kanfer, 2013-10-24 In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral |
| fda guidelines for technology transfer: Human Genome Editing National Academies of Sciences, Engineering, and Medicine, National Academy of Medicine, National Academy of Sciences, Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations, 2017-08-13 Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing. |
| fda guidelines for technology transfer: Biodesign Stefanos Zenios, Josh Makower, Paul Yock, 2010 Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. Outlining a systematic, proven approach for innovation - identify, invent, implement - and integrating medical, engineering, and business challenges with real-world case studies, this book provides a practical guide for students and professionals. |
| fda guidelines for technology transfer: The Changing Economics of Medical Technology Institute of Medicine, Committee on Technological Innovation in Medicine, 1991-02-01 Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€as well as the involvement of numerous government agenciesâ€affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public. |
| fda guidelines for technology transfer: Pharmaceutical Preformulation and Formulation Mark Gibson, 2016-04-19 Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne |
| fda guidelines for technology transfer: Serial Innovators Abbie Griffin, Raymond L. Price, Bruce Vojak, 2012-05-30 Serial Innovators: How Individuals Create and Deliver Breakthrough Innovations in Mature Firms zeros in on the cutting-edge thinkers who repeatedly create and deliver breakthrough innovations and new products in large, mature organizations. These employees are organizational powerhouses who solve consumer problems and substantially contribute to the financial value to their firms. In this pioneering study, authors Abbie Griffin, Raymond L. Price, and Bruce A. Vojak detail who these serial innovators are and how they develop novel products, ranging from salt-free seasonings to improved electronics in companies such as Alberto Culver, Hewlett-Packard, and Procter & Gamble. Based on interviews with over 50 serial innovators and an even larger pool of their co-workers, managers and human resources teams, the authors reveal key insights about how to better understand, emulate, enable, support, and manage these unique and important individuals for long-term corporate success. Interestingly, the book finds that serial innovators are instrumental both in cases where firms are aware of clear market demands, and in scenarios when companies take risks on new investments, creating a consumer need. For over 25 years, research on innovation has taken the perspective that new product development can be managed like any other (complex) process of the firm. While a highly structured and closely supervised approach is helpful in creating incremental innovations, this book finds that it is not conducive to creating breakthrough innovations. The text argues that the drive to routinize innovation has gone too far; in fact, so far as to limit many mature firms' ability to create breakthrough innovations. In today's economy, with the future of so many large firms on the line, this book is a clarion call to businesses to rethink how to nurture and thrive on their innovative workforce. |
| fda guidelines for technology transfer: Standards and Labeling Policy Book United States. Food Safety and Inspection Service. Standards and Labeling Division, 1991 |
| fda guidelines for technology transfer: OECD Guidelines for the Testing of Chemicals, Section 4 Test No. 471: Bacterial Reverse Mutation Test OECD, 1997-07-21 The bacterial reverse mutation test uses amino-acid requiring at least five strains of Salmonella typhimurium and Escherichia coli to detect point mutations by base substitutions or frameshifts. The principle of this bacterial reverse mutation test ... |
| fda guidelines for technology transfer: FDA Regulation of Medical Devices Judith A. Johnson, 2012-07-06 On June 20, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, S. 3187 (EAH), the Food and Drug Administration Safety and Innovation Act, as amended. This bill would reauthorize the FDA prescription drug and medical device user fee programs (which would otherwise expire on September 30, 2012), create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. It reflects bicameral compromise on earlier versions of the bill (S. 3187 [ES], which passed the Senate on May 24, 2012, and H.R. 5651 [EH], which passed the House on May 30, 2012). The following CRS reports provide overview information on FDA's processes for approval and regulation of drugs: CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness, by Susan Thaul; CRS Report RL33986, FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective, by Susan Thaul; CRS Report R42130, FDA Regulation of Medical Devices, by Judith A. Johnson; CRS Report R42508, The FDA Medical Device User Fee Program, by Judith A. Johnson. (Note: The rest of this report has not been updated since December 28, 2011.) Prior to and since the passage of the Medical Device Amendments of 1976, Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system. In order to be legally marketed in the United States, many medical devices must be reviewed by the Food and Drug Administration (FDA), the agency responsible for protecting the public health by overseeing medical products, including devices. FDA's Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. CDRH activities are funded through a combination of public money (i.e., direct FDA appropriations from Congress) and private money (i.e., user fees collected from device manufacturers) which together comprise FDA's total. User fees account for 33% of FDA's total FY2011 program level and 15% of CDRH's program level, which is $378 million in FY2011 including $56 million in user fees. FDA's authority to collect user fees, originally authorized in 2002 (P.L. 107-250), has been reauthorized in five-year increments. It will expire on October 1, 2012, under the terms of the Medical Device User Fee Act of 2007 (MDUFA), Title II of the FDA Amendments Act of 2007 (FDAAA, P.L. 110-85). FDA requires all medical product manufacturers to register their facilities, list their devices with FDA, and follow general controls requirements. FDA classifies devices according to the risk they pose to consumers. Premarket review is required for moderate- and high-risk devices. There are two paths that manufacturers can use to bring such devices to market. One path consists of conducting clinical studies, submitting a premarket approval (PMA) application and requires evidence providing reasonable assurance that the device is safe and effective. The other path involves submitting a 510(k) notification demonstrating that the device is substantially equivalent to a device already on the market (a predicate device) that does not require a PMA. The 510(k) process results in FDA clearance and tends to be much less expensive and less time- consuming than seeking FDA approval via PMA. |
| fda guidelines for technology transfer: FTO (freedom to Operate) in the Pharmaceutical Industry Hirotaka Nonaka, 2018 Key features of innovation in the pharmaceutical industry -- How to achieve freedom to operate (FTO) -- Dealing with adverse patents -- Structure and operation of FTO-licensing markets in the parmaceutical industry -- FTO-licensing between a venture business company for innovative drug development and a pharmaceutical company. |
| fda guidelines for technology transfer: ISPE Good Practice Guide Ispe, 2019-03-25 |
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The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by …
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Find information about most FDA-approved prescription, generic, and over-the-counter drug products. Drug Shortages Find information about drug shortages caused by manufacturing …
What We Do | FDA - U.S. Food and Drug Administration
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the …
About FDA | FDA - U.S. Food and Drug Administration
More than 18,000 FDA employees work in all 50 states and internationally to ensure the safety and effectiveness of human and veterinary medicines, biologics, and medical devices.
Contact FDA | FDA - U.S. Food and Drug Administration
Oct 21, 2024 · View FDA’s proposed regulations and submit comments online (on Regulations.gov). How to comment on proposed regulations or submit petitions. Resolve a …
News & Events | FDA - U.S. Food and Drug Administration
FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public.
FDA Newsroom | FDA - U.S. Food and Drug Administration
Oct 2, 2024 · The latest news and events at the U.S. Food and Drug Administration (FDA) and resources for journalists.
Drug Approvals and Databases | FDA
Novel Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products; Drug and Biologic Approval and IND Activity Reports; This Week's Drug Approvals; Drug …
Recalls, Market Withdrawals, & Safety Alerts | FDA
On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
The FDA approved the first nasal spray for the emergency treatment of allergic reactions, including those that are life-threatening, in adult and pediatric patients who weigh at least 30 …
