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Pediatric Drug Research And The Fda
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Book Synopsis Safe and Effective Medicines for Children by : Institute of Medicine
Download or read book Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pediatric Drug Development by : Andrew E. Mulberg
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2013-05-20 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
Book Synopsis Pediatric Drug Research and the FDA by : Kevin L. Washington
Download or read book Pediatric Drug Research and the FDA written by Kevin L. Washington and published by Nova Science Pub Incorporated. This book was released on 2012-12-25 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: Congress reauthorized two laws in 2007, the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). PREA requires that sponsors conduct pediatric studies for certain products unless the Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) grants a waiver or deferral. On June 20th, 2012, the House of Representatives passed, by voice vote and under suspension of the rules, 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, create new user fee programs for generic and biosimilar drug approvals, and make other revisions to other FDA drug and device approval processes. This book examines how many and what types of products have been studied; describes the number and type of labeling changes and FDA's review periods and describes challenges identified by stakeholders to conducting studies.
Book Synopsis Pediatric Drug Research by : Marcia Crosse
Download or read book Pediatric Drug Research written by Marcia Crosse and published by DIANE Publishing. This book was released on 2007-08 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: About 2/3 of drugs prescribed for children have not been studied & labeled for pediatric use, which places children at risk of being exposed to ineffective treatment or incorrect dosing. The Best Pharm. for Children Act (BPCA), encourages the mfrs. of drugs that still have marketing exclusivity to conduct pediatric drug studies (PDS), as requested by the FDA. If they do so, FDA may extend for 6 mo. the period during which no equivalent generic drugs can be marketed. This report: assessed the extent to which PDS were being conducted under BPCA for on-patent drugs; evaluated the impact of BPCA on labeling drugs for pediatric use & the process by which the labeling was changed; & illustrated the range of diseases treated by the drugs studied under BPCA.
Download or read book Pediatric Drug Research written by and published by DIANE Publishing. This book was released on 2003 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Addressing the Barriers to Pediatric Drug Development by : Institute of Medicine
Download or read book Addressing the Barriers to Pediatric Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2008-08-12 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt: Decades of research have demonstrated that children do not respond to medications in the same way as adults. Differences between children and adults in the overall response to medications are due to profound anatomical, physiological, and developmental differences. Although few would argue that children should receive medications that have not been adequately tested for safety and efficacy, the majority of drugs prescribed for children-50 to 75 percent-have not been tested in pediatric populations. Without adequate data from such testing, prescribing drugs appropriately becomes challenging for clinicians treating children, from infancy through adolescence. Addressing the Barriers to Pediatric Drug Development is the summary of a workshop, held in Washington, D.C. on June 13, 2006, that was organized to identify barriers to the development and testing of drugs for pediatric populations, as well as ways in which the system can be improved to facilitate better treatments for children.
Book Synopsis Rational Therapeutics for Infants and Children by : Institute of Medicine
Download or read book Rational Therapeutics for Infants and Children written by Institute of Medicine and published by National Academies Press. This book was released on 2000-04-07 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.
Book Synopsis Ethical Conduct of Clinical Research Involving Children by : Institute of Medicine
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Book Synopsis FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective by :
Download or read book FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective written by and published by . This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA, P.L. 107-109) and the Pediatric Research Equity Act (PREA, P.L. 108-155) allow the Food and Drug Administration (FDA) to offer financial and regulatory incentives to manufacturers for testing their products for pediatric use. Unless Congress acts, both programs will end on October 1, 2007. FDA has approved for adult use many products never tested in children. Yet clinicians often prescribe them for children believing that the safety and effectiveness demonstrated with adults would hold for younger patients. However, this off-label prescribing results in children receiving ineffective drugs or too much or too little of a potentially useful drug. Some side effects are unique to children, or children of specific ages, including effects on growth and development. Studies show that drugs vary in bioavailability in children, which depends on the maturation and development of organs and other factors. About 75% of drugs have not had pediatric studies. The market has not been able to overcome the economic, ethical, legal, and mechanical obstacles that make manufacturers reluctant to conduct these tests. FDA had tried to spur pediatric drug research through administrative action. With the FDA Modernization Act of 1997 (FDAMA, P.L. 105-115), Congress provided an incentive: in exchange for a manufacturer's completion of pediatric studies according to an FDA written request, FDA would extend its market exclusivity for that product for six months. BPCA gave this program a five-year reauthorization in 2002. From 1997 through November 2006, FDA sent 338 written requests to patent-holding manufacturers; 44% responded and 91% of those conducted the studies and were granted pediatric exclusivity. This resulted in 118 labeling changes -- for 87% of the drugs granted exclusivity, but only 35% of the drugs for which FDA requested studies. BPCA also set up study referral processes through the National Institutes of Health (NIH) for offpatent drugs and on-patent drugs for which the manufacturer declined FDA's request. Those programs have yet to yield labeling changes. To get pediatric use information on the drugs that manufacturers were not studying, in 1998, FDA published the Pediatric Rule requiring that manufacturers submit pediatric testing data at the time of all new drug applications. In 2002, a federal court declared the rule invalid, holding that FDA lacked the statutory authority to promulgate it. Congress gave FDA that authority with PREA. PREA covers drugs and biological products and includes provisions for deferrals, waivers, and the required pediatric assessment of an approved marketed product. From 2003 through 2006, FDA approved more than 372 drugs and biologics; there have been 63 PREA-related labeling changes. The FDA Revitalization Act (S. 1082, as reported) contains pediatric research provisions, including the continuing of BPCA and PREA. Updates of this report will reflect legislative activity.
Book Synopsis Pediatric Drug Development by : Andrew E. Mulberg
Download or read book Pediatric Drug Development written by Andrew E. Mulberg and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 843 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pediatric Drug Development: Concepts and Applications is designed as a reference and textbook and is meant to address the science of differences between the pediatric and adult subject in the development of pharmaceutical products. Considered are the ethics and medical needs of proper understanding the pediatric and adult differences, the business case for proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a proper pediatric drug development program. The applications of these approaches will benefit all stakeholders and ultimately not only educate but also provide better and safer drugs for pediatric patients.
Book Synopsis General Considerations for the Clinical Evaluation of Drugs by : United States. Food and Drug Administration. Bureau of Drugs
Download or read book General Considerations for the Clinical Evaluation of Drugs written by United States. Food and Drug Administration. Bureau of Drugs and published by . This book was released on 1977 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States Government Accountability Office Publisher :Createspace Independent Publishing Platform ISBN 13 :9781978456372 Total Pages :34 pages Book Rating :4.4/5 (563 download)
Book Synopsis Pediatric Drug Research by : United States Government Accountability Office
Download or read book Pediatric Drug Research written by United States Government Accountability Office and published by Createspace Independent Publishing Platform. This book was released on 2017-10-21 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pediatric Drug Research: Food and Drug Administration Should More Efficiently Monitor Inclusion of Minority Children
Book Synopsis Guide to Paediatric Drug Development and Clinical Research by : Klaus Rose
Download or read book Guide to Paediatric Drug Development and Clinical Research written by Klaus Rose and published by Karger Medical and Scientific Publishers. This book was released on 2010-01-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child's body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects.A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.
Book Synopsis Pediatric Non-Clinical Drug Testing by : Alan M. Hoberman
Download or read book Pediatric Non-Clinical Drug Testing written by Alan M. Hoberman and published by John Wiley & Sons. This book was released on 2011-12-28 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explains the importance and practice of pediatric drug testing for pharmaceutical and toxicology professionals. It describes the practical and ethical issues regarding non-clinical testing to meet US FDA Guidelines, differences resulting from the new European EMEA legislation, and how to develop appropriate information for submission to both agencies. It also provides practical study designs and approaches that can be used to meet international requirements. Covering the full scope of non-clinical testing, regulations, models, practice, and relation to clinical trials, this text offers a comprehensive and up-to-date resource.
Book Synopsis FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective by : Susan Thaul
Download or read book FDA's Authority to Ensure That Drugs Prescribed to Children Are Safe and Effective written by Susan Thaul and published by Createspace Independent Pub. This book was released on 2012-07-06 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 November 10, 2011.) With the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), Congress authorized the Food and Drug Administration (FDA) to offer drug manufacturers financial and regulatory incentives to test their products for use in children. Congress extended both programs with the FDA Amendments of 2007 (FDAAA) and, because of the programs' sunset date, must act before October 1, 2012, to continue them. This report presents the historical development of BPCA and PREA, their rationale and effect, and FDAAA's impact. The report also discusses pediatric drug issues that remain of concern to some in Congress. Most prescription drugs have never been the subject of studies specifically designed to test their effects on children. In these circumstances, clinicians, therefore, may prescribe drugs for children that FDA has approved only for adult use; this practice is known as off-label prescribing. Although some clinicians may believe that the safety and effectiveness demonstrated with adults would hold for younger patients, studies show that the bioavailability of drugs—that is, how much gets into a patient's system and is available for use—varies in children for reasons that include a child's maturation and organ development and other factors. The result of such off-label prescribing may be that some children receive ineffective drugs or too much or too little of potentially useful drugs; or that there may be side effects unique to children, including effects on growth and development. Drug manufacturers are reluctant to test drugs in children because of economic, ethical, legal, and other obstacles. Market forces alone have not provided manufacturers with sufficient incentives to overcome these obstacles. BPCA and PREA represent attempts by Congress to address the need for pediatric testing. FDA had tried unsuccessfully to spur pediatric drug research through administrative action before 1997. With the FDA Modernization Act of 1997 (FDAMA, P.L. 105-115), Congress provided an incentive: if a manufacturer completed pediatric studies that FDA requested, the agency would extend the company's market exclusivity for that product for six months, not approving the sale of another manufacturer's product during that period. In 2002, BPCA (P.L. 107-109) reauthorized this program for five years. In 1998, to obtain pediatric use information on the drugs that manufacturers were not studying, FDA published the Pediatric Rule, which required manufacturers to submit pediatric testing data at the time of all new drug applications.
Book Synopsis Rare Diseases and Orphan Products by : Institute of Medicine
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Publisher : ISBN 13 : Total Pages :184 pages Book Rating :4.3/5 (91 download)
Book Synopsis Research Involving Children by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Download or read book Research Involving Children written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1977 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
