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| fda special protocol assessment: Guideline on General Principles of Process Validation , 1987 |
| fda special protocol assessment: Bayesian Adaptive Methods for Clinical Trials Scott M. Berry, Bradley P. Carlin, J. Jack Lee, Peter Muller, 2010-07-19 Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV. Written by leading pioneers of Bayesian clinical trial designs, Bayesian Adapti |
| fda special protocol assessment: The Prevention and Treatment of Missing Data in Clinical Trials National Research Council, Division of Behavioral and Social Sciences and Education, Committee on National Statistics, Panel on Handling Missing Data in Clinical Trials, 2010-12-21 Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data. |
| fda special protocol assessment: 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 special protocol assessment: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| fda special protocol assessment: FDA's Drug Review Process and the Package Label Tom Brody, 2017-12-01 FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. - Reveals strategies for winning FDA approval and for drafting the package label - Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases - This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug |
| fda special protocol assessment: Pain Management and the Opioid Epidemic National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse, 2017-09-28 Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring. |
| fda special protocol assessment: Safe and Effective Medicines for Children Institute of Medicine, Board on Health Sciences Policy, Committee on Pediatric Studies Conducted Under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), 2012-10-13 The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children. |
| fda special protocol assessment: The Future of Drug Safety Institute of Medicine, Board on Population Health and Public Health Practice, Committee on the Assessment of the US Drug Safety System, 2007-03-27 In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used. |
| fda special protocol assessment: Guideline for Submitting Samples and Analytical Data for Methods Validation , 1987 |
| fda special protocol assessment: 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 special protocol assessment: Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease Institute of Medicine, Food and Nutrition Board, Board on Health Sciences Policy, Board on Health Care Services, Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, 2010-06-25 Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process. |
| fda special protocol assessment: Pharmaceutical Process Validation Bernard T. Loftus, Robert A. Nash, 1984 |
| fda special protocol assessment: An Overview of FDA Regulated Products Eunjoo Pacifici, Susan Bain, 2018-06-13 Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations |
| fda special protocol assessment: Implementing a National Cancer Clinical Trials System for the 21st Century Institute of Medicine, Board on Health Care Services, National Cancer Policy Forum, 2011-09-19 Clinical trials enable scientific discoveries to advance patient care, in addition to informing and guiding subsequent research. The National Cancer Institute's (NCI's) Clinical Trials Cooperative Group Program works to advance patient care and research. The Cooperative Group Program has been instrumental in establishing the standards for cancer patient care and clinical research methods. Despite broad participation in the program, financial strain and procedural burdens limit the ability of the Cooperative Group Program to undertake medical practice-changing clinical research. Thus, the Institute of Medicine's (IOM's) National Cancer Policy Forum and the American Society of Clinical Oncology held a workshop on March 21, 2011 to follow up on the 2010 IOM report, A National Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, which made recommendations to strengthen the NCI Cooperative Group Program. In keeping with the established commitment to excellence Implementing a National Cancer Clinical Trials System for the 21st Century outlines how to improve the current system by incorporating innovative science and trial design into cancer clinical trials. It also examines the impact of increasing quality in regards to speed, efficiency, design, launch, and conduct, as well as improving prioritization, and incentivized participation. |
| fda special protocol assessment: 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 special protocol assessment: 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 special protocol assessment: The Use of Drugs in Food Animals National Research Council, Institute of Medicine, Food and Nutrition Board, Board on Agriculture, Committee on Drug Use in Food Animals, Panel on Animal Health, Food Safety, and Public Health, 1999-01-12 The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management. |
| fda special protocol assessment: Dietary Supplements United States. Federal Trade Commission. Bureau of Consumer Protection, 1998 |
| fda special protocol assessment: 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 special protocol assessment: Clinical Trials Tom Brody, 2016-02-19 Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. - Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more - Extensively covers the study schema and related features of study design - Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials - Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers |
| fda special protocol assessment: Examining the Impact of Real-World Evidence on Medical Product Development National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Drug Discovery, Development, and Translation, 2019-04-05 Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series. |
| fda special protocol assessment: The Belmont Report United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978 |
| fda special protocol assessment: Reinventing Regulation of Drugs and Medical Devices Bill Clinton, 1995 |
| fda special protocol assessment: Regulating Artificial Intelligence Thomas Wischmeyer, Timo Rademacher, 2019-11-29 This book assesses the normative and practical challenges for artificial intelligence (AI) regulation, offers comprehensive information on the laws that currently shape or restrict the design or use of AI, and develops policy recommendations for those areas in which regulation is most urgently needed. By gathering contributions from scholars who are experts in their respective fields of legal research, it demonstrates that AI regulation is not a specialized sub-discipline, but affects the entire legal system and thus concerns all lawyers. Machine learning-based technology, which lies at the heart of what is commonly referred to as AI, is increasingly being employed to make policy and business decisions with broad social impacts, and therefore runs the risk of causing wide-scale damage. At the same time, AI technology is becoming more and more complex and difficult to understand, making it harder to determine whether or not it is being used in accordance with the law. In light of this situation, even tech enthusiasts are calling for stricter regulation of AI. Legislators, too, are stepping in and have begun to pass AI laws, including the prohibition of automated decision-making systems in Article 22 of the General Data Protection Regulation, the New York City AI transparency bill, and the 2017 amendments to the German Cartel Act and German Administrative Procedure Act. While the belief that something needs to be done is widely shared, there is far less clarity about what exactly can or should be done, or what effective regulation might look like. The book is divided into two major parts, the first of which focuses on features common to most AI systems, and explores how they relate to the legal framework for data-driven technologies, which already exists in the form of (national and supra-national) constitutional law, EU data protection and competition law, and anti-discrimination law. In the second part, the book examines in detail a number of relevant sectors in which AI is increasingly shaping decision-making processes, ranging from the notorious social media and the legal, financial and healthcare industries, to fields like law enforcement and tax law, in which we can observe how regulation by AI is becoming a reality. |
| fda special protocol assessment: Marijuana and Medicine Institute of Medicine, 1999-07-10 The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers. |
| fda special protocol assessment: Toxicokinetics , 1995 |
| fda special protocol assessment: The Social Impact of AIDS in the United States National Research Council, Division of Behavioral and Social Sciences and Education, Commission on Behavioral and Social Sciences and Education, Panel on Monitoring the Social Impact of the AIDS Epidemic, 1993-02-01 Europe's Black Death contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals. |
| fda special protocol assessment: General Considerations for the Clinical Evaluation of Drugs United States. Food and Drug Administration. Bureau of Drugs, 1977 |
| fda special protocol assessment: DeVita, Hellman, and Rosenberg's Cancer Vincent T. DeVita, Theodore S. Lawrence, Steven A. Rosenberg, 2008 Presenting comprehensive, cutting-edge information on the science of oncology and the multimodality treatment of every cancer type, this eighth edition--now in full color--contains more than 40 brand-new chapters, and more than 70 chapters have been rewritten by new contributing authors. |
| fda special protocol assessment: Regulation of Biological Products National Institutes of Health (U.S.). Division of Biologics Standard, 1960 |
| fda special protocol assessment: Microbiology Laboratory Guidebook United States. Food Safety and Inspection Service. Microbiology Division, 1998 |
| fda special protocol assessment: Generic Drug Product Development Isadore Kanfer, Leon Shargel, 2016-04-19 Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutica |
| fda special protocol assessment: Designs for Clinical Trials David Harrington, 2011-10-09 This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials. |
| fda special protocol assessment: CDC Yellow Book 2018: Health Information for International Travel Centers for Disease Control and Prevention CDC, 2017-04-17 THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad. |
| fda special protocol assessment: Current Challenges in Pharmacovigilance World Health Organization, Council for International Organizations of Medical Sciences, Cioms, 2001-01-01 In spite of recent progress in the harmonization of terminology and processes affecting work on the clinical safety of medicines consensus is needed on standards for many difficult aspects of day-to-day pharmacovigilance that continue to pose problems for both the pharmaceutical industry and drug regulators. The CIOMS V Working Group has generated proposals for pragmatic approaches to dealing with such issues as: classification and handling of individual safety case reports from a variety of sources (spontaneous consumer reports solicited reports literature the Internet observational studies and secondary data bases disease and other registries regulatory ADR databases and licensor-licensee interactions); new approaches to case management and regulatory reporting practices (proper clinical evaluation of cases incidental vs other events patient and reporter identifiability seriousness criteria expectedness criteria case follow-up criteria and the role and structure of case narratives); improvements and efficiencies in the format content and reporting of periodic safety update reports (PSURs) (including results of an industry survey on PSUR workloads and practices; proposals for high case volume and long time-period reports simplification of certain PSURs summary bridging reports addendum reports license renewal reports for EU and Japan dealing with old products and other technical details); determination and use of population exposure (denominator) data (sources of data and a guide to analytical approaches for a variety of circumstances).The Group has also taken stock of the current state of expedited and periodic clinical safety reporting requirements around the world with summary data on regulations from more than 60 countries. Recommendations are made for enhancing the harmonization steps already taken as a result of previous CIOMS publications and the ICH process. In addition to dealing with unfinished and unresolved issues from previous CIOMS initiatives the report covers many emerging topics such as those involving new technologies. Its 20 Appendices provide a wealth of detailed explanations and reference information. It is the most comprehensive and recent treatment of difficult pharmacovigilance issues affecting the working practices and systems of drug safety and other pharmaceutical professionals. |
| fda special protocol assessment: Bad Bug Book Mark Walderhaug, 2014-01-14 The Bad Bug Book 2nd Edition, released in 2012, provides current information about the major known agents that cause foodborne illness.Each chapter in this book is about a pathogen—a bacterium, virus, or parasite—or a natural toxin that can contaminate food and cause illness. The book contains scientific and technical information about the major pathogens that cause these kinds of illnesses.A separate “consumer box” in each chapter provides non-technical information, in everyday language. The boxes describe plainly what can make you sick and, more important, how to prevent it.The information provided in this handbook is abbreviated and general in nature, and is intended for practical use. It is not intended to be a comprehensive scientific or clinical reference.The Bad Bug Book is published by the Center for Food Safety and Applied Nutrition (CFSAN) of the Food and Drug Administration (FDA), U.S. Department of Health and Human Services. |
| fda special protocol assessment: Frenchay Dysarthria Assessment Pamela M. Enderby, 1988 |
| fda special protocol assessment: Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2016: Statements of interested individuals and organizations United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, 2015 |
| fda special protocol assessment: Treatment Improvement Protocol (TIP) 63: Medications for Opioid Use Disorder Substance Abuse Mental Health Services Administration/SAMHSA (U.S.), 2018-06-05 This Treatment Improvement Protocol (TIP) reviews the use of the three Food and Drug Administration (FDA)-approved medications used to treat opioid use disorder (OUD)—methadone, naltrexone, and buprenorphine—and provides guidance for healthcare professionals and addiction treatment providers on appropriate prescribing practices for these medications and effective strategies for supporting the patients utilizing medication for the treatment of OUD. The goal of treatment for opioid addiction or OUD is remission of the disorder leading to lasting recovery. Recovery is a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their full potential. This TIP also educates patients, families, and the general public about how OUD medications work and the benefits they offer. Related products: Medication-Assisted Treatment of Opioid Use Disorder: Pocket Guide A Shared Burden: The Military and Civilian Consequences of Army Pain Management Since 2001 Click our Alcoholism, Smoking & Substance Abuse collection to find more resources on this topic. |
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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 …
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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 …
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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.
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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 …
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FDA news releases, media contacts, speeches, meetings and workshops, and other ways that FDA engages with the public.
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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 …
U.S. Food and Drug Administration
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 …
Drugs | FDA - U.S. Food and Drug Administration
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 …
