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Author : Anonim
Publisher : DIANE Publishing
Page : 52 pages
File Size : 47,8 Mb
Release : 2024-06-15
Category : Electronic
ISBN : 1422311570
Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 52 pages
File Size : 42,9 Mb
Release : 2017-09-13
Category : Electronic
ISBN : 1976365120
The Food and Drug Administration (FDA) is responsible for overseeing direct-to-consumer (DTC) advertising of prescription drugs. If FDA identifies a violation of laws or regulations in a DTC advertising material, the agency may issue a regulatory letter asking the drug company to take specific actions. GAO was asked to discuss (1) trends in drug company spending on DTC advertising and other activities; (2) what is known about the relationship between DTC advertising and drug spending and utilization; (3) the DTC advertising materials FDA reviews; (4) the number of regulatory letters that cited DTC materials and FDA's process for issuing those letters; and (5) the effectiveness of these letters at limiting the dissemination of violative DTC advertising. GAO reviewed research literature, analyzed FDA's processes, and examined FDA documentation.
Author : United States Government Accountability Office
Publisher : Createspace Independent Publishing Platform
Page : 34 pages
File Size : 43,9 Mb
Release : 2018-05-17
Category : Electronic
ISBN : 1719258651
Prescription Drugs: Trends in FDA's Oversight of Direct-to-Consumer Advertising
Author : Anonim
Publisher : Unknown
Page : 128 pages
File Size : 55,7 Mb
Release : 2006
Category : Electronic
ISBN : OCLC:1229734819
Author : Marcia Crosse
Publisher : DIANE Publishing
Page : 19 pages
File Size : 48,5 Mb
Release : 2008-10
Category : Business & Economics
ISBN : 9781437905717
The FDA is responsible for overseeing direct-to-consumer (DTC) advertising (ad) of prescription drugs, which includes TV, magazines, and the Internet. If FDA identifies a violation of laws or reg¿s. in a DTC ad material, the agency may issue a regulatory letter (RL) asking the drug co. to take specific actions. In 2002, there were delays in FDA¿s issuance of these RL. This testimony discusses trends in FDA¿s oversight of DTC ad and the actions FDA has taken when it identifies violations. This statement discusses the: (1) DTC ad materials FDA reviews; (2) FDA¿s process for issuing RL citing DTC ad materials and the number of RL issued; and (3) the effectiveness of FDA¿s RL at limiting the dissemination of false or misleading DTC ad. Charts and tables.
Author : Anonim
Publisher : DIANE Publishing
Page : 37 pages
File Size : 43,7 Mb
Release : 2024-06-15
Category : Electronic
ISBN : 9781428945531
Author : United States. General Accounting Office
Publisher : Unknown
Page : 128 pages
File Size : 45,6 Mb
Release : 2002
Category : Advertising
ISBN : OCLC:52847571
Author : Marcia Crosse
Publisher : Unknown
Page : 15 pages
File Size : 47,9 Mb
Release : 2008
Category : Direct-to-consumer prescription drug advertising
ISBN : OCLC:231620845
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of the US Drug Safety System
Publisher : National Academies Press
Page : 346 pages
File Size : 46,8 Mb
Release : 2007-02-27
Category : Medical
ISBN : 9780309133944
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.
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
Page : 483 pages
File Size : 53,7 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
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.
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher : Unknown
Page : 556 pages
File Size : 50,8 Mb
Release : 2008
Category : Law
ISBN : UOM:39015089026978
Author : Holly Fernandez Lynch,I. Glenn Cohen
Publisher : Columbia University Press
Page : 499 pages
File Size : 50,7 Mb
Release : 2015-09-08
Category : Business & Economics
ISBN : 9780231540070
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Author : 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
Publisher : National Academies Press
Page : 335 pages
File Size : 43,5 Mb
Release : 2010-06-25
Category : Medical
ISBN : 9780309157278
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.
Author : Carol J. Pardun
Publisher : John Wiley & Sons
Page : 346 pages
File Size : 45,7 Mb
Release : 2013-06-26
Category : Business & Economics
ISBN : 9781118587621
Now revised and updated to reflect the impact of emerging technologies, this new edition of Advertising and Society: Controversies and Consequences examines the evolution of advertising and its influence on society. Expanded with five new chapters covering the impact of emerging technologies, including the evolution of Direct to Consumer (DTC) pharmaceutical advertising; product placement in various media; and the growing intrusiveness of Internet marketing Explores a broad range of topics including alcohol, tobacco, and sex in advertising; the pros and cons of negative political adverts; advergrames; and the use of stereotypes Examines the impact of advertising through its distinctive ‘point/counterpoint’ format –designed to spark discussion and help students understand the complexities of the issues being presented Lends substantial clarity to the subject, uniquely balancing criticism and practice within one text Includes chapter-level overviews and summaries of the topic history and key issues, along with student-friendly features such as ideas for papers and questions for discussion
Author : Institute of Medicine,Board on Population Health and Public Health Practice,Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs
Publisher : National Academies Press
Page : 292 pages
File Size : 52,8 Mb
Release : 2012-07-30
Category : Medical
ISBN : 9780309218160
An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.