Fdas Drug Review Process And The Package Label

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FDA's Drug Review Process and the Package Label

FDA's Drug Review Process and the Package Label
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2017-12-13
  • Total pages : 670
  • ISBN : 9780128146484
  • File Size : 51,6 Mb
  • Total Download : 839
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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's Drug Review Process and the Package Label

FDA's Drug Review Process and the Package Label
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2017-12
  • Total pages : 670
  • ISBN : 0128146478
  • File Size : 24,9 Mb
  • Total Download : 987
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Download FDA's Drug Review Process and the Package Label in PDF, Epub, and Kindle

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

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
  • Author : 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
  • Publisher : National Academies Press
  • Release Date : 2017-10-28
  • Total pages : 483
  • ISBN : 9780309459549
  • File Size : 25,9 Mb
  • Total Download : 375
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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.

How FDA Approves Drugs and Regulates Their Safety and Effectiveness

How FDA Approves Drugs and Regulates Their Safety and Effectiveness
  • Author : Susan Thaul
  • Publisher : CreateSpace
  • Release Date : 2012-07-03
  • Total pages : 26
  • ISBN : 1478182229
  • File Size : 46,8 Mb
  • Total Download : 185
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Update: 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 September 1, 2011.) The Food and Drug Administration (FDA) is a regulatory agency within the Department of Health and Human Services. A key responsibility is to regulate the safety and effectiveness of drugs sold in the United States. FDA divides that responsibility into two phases: preapproval (premarket) and postapproval (postmarket). FDA reviews manufacturers' applications to market drugs in the United States; a drug may not be sold unless it has FDA approval. The agency continues its oversight of drug safety and effectiveness as long as the drug is on the market. Beginning with the Food and Drugs Act of 1906, Congress has incrementally refined and expanded FDA's responsibilities regarding drug approval and regulation. The progression to drug approval begins before FDA involvement. First, basic scientists work in the laboratory and with animals; second, a drug or biotechnology company develops a prototype drug. That company must seek and receive FDA approval, by way of an investigational new drug (IND) application, to test the product with human subjects. Those tests, called clinical trials, are carried out sequentially in Phase I, II, and III studies, which involve increasing numbers of subjects. The manufacturer then compiles the resulting data and analysis in a new drug application (NDA). FDA reviews the NDA with three major concerns: (1) safety and effectiveness in the drug's proposed use; (2) appropriateness of the proposed labeling; and (3) adequacy of manufacturing methods to assure the drug's identify, strength, quality, and identity. The Federal Food, Drug, and Cosmetic Act (FFDCA) and associated regulations detail the requirements at each step. FDA uses a few special mechanisms to expedite drug development and the review process when a drug might address an unmet need or a serious disease or condition. Those mechanisms include accelerated approval, animal efficacy approval, fast track applications, and priority review. Once a drug is on the U.S. market (following FDA approval of the NDA), FDA continues to address drug production, distribution, and use. Its activities, based on ensuring drug safety and effectiveness, address product integrity, labeling, reporting of research and adverse events, surveillance, drug studies, risk management, information dissemination, off-label use, and directto- consumer advertising, all topics in which Congress has traditionally been interested. FDA seeks to ensure product integrity through product and facility registration; inspections; chain-of-custody documentation; and technologies to protect against counterfeit, diverted, subpotent, adulterated, misbranded, and expired drugs.~

Front-of-Package Nutrition Rating Systems and Symbols

Front-of-Package Nutrition Rating Systems and Symbols
  • Author : Institute of Medicine,Food and Nutrition Board,Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols
  • Publisher : National Academies Press
  • Release Date : 2010-12-21
  • Total pages : 140
  • ISBN : 0309186528
  • File Size : 33,9 Mb
  • Total Download : 489
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The federal government requires that most packaged foods carry a standardized label--the Nutrition Facts panel--that provides nutrition information intended to help consumers make healthful choices. In recent years, manufacturers have begun to include additional nutrition messages on their food packages. These messages are commonly referred to as 'front-of-package' (FOP) labeling. As FOP labeling has multiplied, it has become easy for consumers to be confused about critical nutrition information. In considering how FOP labeling should be used as a nutrition education tool in the future, Congress directed the Centers for Disease Control and Prevention to undertake a two-phase study with the IOM on FOP nutrition rating systems and nutrition-related symbols. The Food and Drug Administration is also a sponsor. In Phase 1 of its study, the IOM reviewed current systems and examined the strength and limitations of the nutrition criteria that underlie them. The IOM concludes that it would be useful for FOP labeling to display calorie information and serving sizes in familiar household measures. In addition, as FOP systems may have the greatest benefit if the nutrients displayed are limited to those most closely related to prominent health conditions, FOP labeling should provide information on saturated fats, trans fats, and sodium.

Clinical Trials

Clinical Trials
  • Author : Tom Brody
  • Publisher : Academic Press
  • Release Date : 2016-02-19
  • Total pages : 896
  • ISBN : 9780128042588
  • File Size : 32,9 Mb
  • Total Download : 462
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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

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes
  • Author : Agency for Healthcare Research and Quality/AHRQ
  • Publisher : Government Printing Office
  • Release Date : 2014-04-01
  • Total pages : 356
  • ISBN : 9781587634338
  • File Size : 30,6 Mb
  • Total Download : 453
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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 Drug Review

FDA Drug Review
  • Author : United States. General Accounting Office
  • Publisher : Unknown
  • Release Date : 1990
  • Total pages : 136
  • ISBN : UOM:39015042648793
  • File Size : 31,9 Mb
  • Total Download : 708
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PDF book entitled FDA Drug Review written by United States. General Accounting Office and published by Unknown which was released on 1990 with total hardcover pages 136, the book become popular and critical acclaim.

FDA's Drug Approval Process

FDA's Drug Approval Process
  • Author : United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
  • Publisher : Unknown
  • Release Date : 2005
  • Total pages : 100
  • ISBN : PURD:32754077529000
  • File Size : 12,9 Mb
  • Total Download : 290
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PDF book entitled FDA's Drug Approval Process written by United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions and published by Unknown which was released on 2005 with total hardcover pages 100, the book become popular and critical acclaim.

A Food Labeling Guide

A Food Labeling Guide
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1999
  • Total pages : 72
  • ISBN : MINN:31951D01920846O
  • File Size : 45,5 Mb
  • Total Download : 878
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PDF book entitled A Food Labeling Guide written by Anonim and published by Unknown which was released on 1999 with total hardcover pages 72, the book become popular and critical acclaim.

FDA Regulatory Affairs

FDA Regulatory Affairs
  • Author : David Mantus,Douglas J. Pisano
  • Publisher : CRC Press
  • Release Date : 2014-02-28
  • Total pages : 402
  • ISBN : 9781841849195
  • File Size : 49,5 Mb
  • Total Download : 278
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FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

Approved Prescription Drug Products with Therapeutic Equivalence Evaluations

Approved Prescription Drug Products with Therapeutic Equivalence Evaluations
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1984
  • Total pages : 229
  • ISBN : UOM:39015072931507
  • File Size : 37,8 Mb
  • Total Download : 661
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Accompanied by supplements.

The Use of Drugs in Food Animals

The Use of Drugs in Food Animals
  • Author : National Research Council,Board on Agriculture,Panel on Animal Health, Food Safety, and Public Health,Committee on Drug Use in Food Animals
  • Publisher : National Academies Press
  • Release Date : 1999-01-12
  • Total pages : 276
  • ISBN : 0309175771
  • File Size : 10,9 Mb
  • Total Download : 103
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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 industries--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. November

Immunotherapy for Gastrointestinal Malignancies

Immunotherapy for Gastrointestinal Malignancies
  • Author : Ramakrishna Vadde,Ganji Purnachandra Nagaraju
  • Publisher : Springer Nature
  • Release Date : 2021-01-31
  • Total pages : 251
  • ISBN : 9789811564871
  • File Size : 9,6 Mb
  • Total Download : 123
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This book reviews current immunotherapeutic strategies for gastrointestinal (GI) malignancies, including immune composition, immune checkpoint inhibitors, cell therapy, and peptide vaccines used to protect against esophageal, gastric, hepato-biliary, pancreatic and colorectal cancers. It also discusses the current challenges of using immunotherapy for the treatment of gastrointestinal malignancies. The book reviews highly sensitive and specific immunomarkers for the detection of GI malignancies, and examines therapeutic vaccines and the major cytokines involved in GI immunotherapy, as well as their basic biology and clinical applications. In closing, the book explores various aspects of computational biology for the detection and treatment of GI malignancies.

FDA General Information and Label Review Procedures

FDA General Information and Label Review Procedures
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1985
  • Total pages : 8
  • ISBN : MINN:31951002934625S
  • File Size : 51,6 Mb
  • Total Download : 347
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PDF book entitled FDA General Information and Label Review Procedures written by Anonim and published by Unknown which was released on 1985 with total hardcover pages 8, the book become popular and critical acclaim.

Foye's Principles of Medicinal Chemistry

Foye's Principles of Medicinal Chemistry
  • Author : David A. Williams,William O. Foye,Thomas L. Lemke
  • Publisher : Lippincott Williams & Wilkins
  • Release Date : 2002
  • Total pages : 1136
  • ISBN : 9780683307375
  • File Size : 50,7 Mb
  • Total Download : 732
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This comprehensive Fifth Edition has been fully revised and updated to meet the changing curricula of medicinal chemistry courses. The new emphasis is on pharmaceutical care that focuses on the patient, and on the pharmacist a therapeutic clinical consultant, rather than chemist. Approximately 45 contributors, respected in the field of pharmacy education, augment this exhaustive reference. New to this edition are chapters with standardized formats and features, such as Case Studies, Therapeutic Actions, Drug Interactions, and more. Over 700 illustrations supplement this must-have resource.

FDA Consumer

FDA Consumer
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 292
  • ISBN : MINN:31951P00953400R
  • File Size : 31,6 Mb
  • Total Download : 206
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PDF book entitled FDA Consumer written by Anonim and published by Unknown which was released on 2006 with total hardcover pages 292, the book become popular and critical acclaim.

Off-label Drug Use and FDA Review of Supplemental Drug Applications

Off-label Drug Use and FDA Review of Supplemental Drug Applications
  • Author : United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations
  • Publisher : Unknown
  • Release Date : 1997
  • Total pages : 158
  • ISBN : PURD:32754067880207
  • File Size : 18,7 Mb
  • Total Download : 322
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PDF book entitled Off-label Drug Use and FDA Review of Supplemental Drug Applications written by United States. Congress. House. Committee on Government Reform and Oversight. Subcommittee on Human Resources and Intergovernmental Relations and published by Unknown which was released on 1997 with total hardcover pages 158, the book become popular and critical acclaim.

Essentials of Pharmacy Law

Essentials of Pharmacy Law
  • Author : Douglas J. Pisano
  • Publisher : Routledge
  • Release Date : 2019-08-08
  • Total pages : 136
  • ISBN : 9781000709902
  • File Size : 24,6 Mb
  • Total Download : 977
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This book is a compilation and commentary of selected laws and regulations pertaining to the general practice of pharmacy in the United States. It is designed to be of assistance to practicing pharmacists, those seeking licensure by reciprocity, and other interested healthcare professionals.

Foye's Principles of Medicinal Chemistry

Foye's Principles of Medicinal Chemistry
  • Author : Thomas L. Lemke,David A. Williams
  • Publisher : Lippincott Williams & Wilkins
  • Release Date : 2008
  • Total pages : 1406
  • ISBN : 0781768799
  • File Size : 33,7 Mb
  • Total Download : 157
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The Sixth Edition of this well-known text has been fully revised and updated to meet the changing curricula of medicinal chemistry courses. Emphasis is on patient-focused pharmaceutical care and on the pharmacist as a therapeutic consultant, rather than a chemist. A new disease state management section explains appropriate therapeutic options for asthma, chronic obstructive pulmonary disease, and men's and women's health problems. Also new to this edition: Clinical Significance boxes, Drug Lists at the beginning of appropriate chapters, and an eight-page color insert with detailed illustrations of drug structures. Case studies from previous editions and answers to this edition's case studies are available online at thePoint.

Safe and Effective Medicines for Children

Safe and Effective Medicines for Children
  • Author : 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)
  • Publisher : National Academies Press
  • Release Date : 2012-10-13
  • Total pages : 432
  • ISBN : 9780309225496
  • File Size : 32,6 Mb
  • Total Download : 986
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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.