Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising

Prescription Drugs: Improvements Needed in FDA’s Oversight of Direct-to-Consumer Advertising PDF Author:
Publisher: DIANE Publishing
ISBN: 9781422311578
Category :
Languages : en
Pages : 52

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Prescription Drugs

Prescription Drugs PDF Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781976365126
Category :
Languages : en
Pages : 52

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Book Description
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.

Direct-to-consumer Advertising

Direct-to-consumer Advertising PDF Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 556

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Book Description


Gao-07-54 Prescription Drugs

Gao-07-54 Prescription Drugs PDF Author: United States Government Accountability Office
Publisher: Createspace Independent Publishing Platform
ISBN: 9781984333780
Category :
Languages : en
Pages : 52

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Book Description
GAO-07-54 Prescription Drugs: Improvements Needed in FDA's Oversight of Direct-to-Consumer Advertising

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic PDF Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309459575
Category : Medical
Languages : en
Pages : 483

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Book Description
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.

The Future of Drug Safety

The Future of Drug Safety PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309103045
Category : Medical
Languages : en
Pages : 347

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Book Description
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.

Pharmacy Practice and The Law

Pharmacy Practice and The Law PDF Author: Richard Abood
Publisher: Jones & Bartlett Learning
ISBN: 0763781290
Category : Law
Languages : en
Pages : 474

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Book Description
The Sixth Edition of this best-selling text includes updates to account for new legal, regulatory and policy developments. Pharmacy Practice and the Law, Sixth Edition provides background, history and discussion of the law so as to enable the student to not only learn the facts, but to help them understand, apply and critically evaluate the information. The issues covered in this text are discussed in non-legal, easy to understand language. Challenging open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Citations to all laws, court cases, regulations and other documents are provided. An online instructor’s manual is available. Pharmacy Practice and the Law, Sixth Edition, is a useful resource both for teaching the facts of pharmacy law and for stimulating critical thinking issues in pharmacy law.

Pharmacy Practice and the Law

Pharmacy Practice and the Law PDF Author: Richard R. Abood
Publisher: Jones & Bartlett Learning
ISBN: 1284154971
Category : Medical
Languages : en
Pages : 421

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Book Description
The Ninth Edition of the best-selling text, Pharmacy Practice and the Law goes beyond preparation for the board exam, helping students understand and critically analyze the law that governs both the profession and the products they distribute. The Ninth Edition continues to include the most up to date federal, legal, regulatory, policy developments, as well as new developments to various medical/pharmaceutical programs. Challenging, open-ended discussion questions and edited cases are included in every chapter to facilitate discussion and critical thinking. Critical issues are discussed in non-legal, easy-to-understand language. Pharmacy Practice and the Law, Ninth Edition is the most comprehensive and engaging resource for teaching the facts of federal pharmacy law and for encouraging critical thinking and analysis on the issues.

American Taboo

American Taboo PDF Author: Lauren Rosewarne
Publisher: Bloomsbury Publishing USA
ISBN:
Category : Social Science
Languages : en
Pages : 264

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Book Description
America's often-unspoken morality codes make many topics taboo in "the land of the free." This book analyzes hundreds of popular culture examples to expose how the media both avoids and alludes to how we derive pleasure from our bodies. Flatulence ... male nudity ... abortion ... masturbation: these are just a few of the taboo topics in the United States. What do culturally enforced silences about certain subjects say about our society—and our latent fears? This work provides a broad yet detailed overview of popular culture's most avoided topics to explain why they remain off-limits and examines how they are presented in contemporary media—or, in many cases, delicately explored using euphemism and innuendo. The author offers fascinating, in-depth analysis of the meaning behind these portrayals of a variety of both mundane and provocative taboos, and identifies how new television programs, films, and advertising campaigns intentionally violate longstanding cultural taboos to gain an edge in the marketplace.

Jonas and Kovner's Health Care Delivery in the United States

Jonas and Kovner's Health Care Delivery in the United States PDF Author:
Publisher: Springer Publishing Company
ISBN: 0826120970
Category : Medical
Languages : en
Pages : 615

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Book Description
How do we understand and also assess the health care of America? Where is health care provided? What are the characteristics of those institutions which provide it? Over the short term, how are changes in health care provisions affecting the health of the population, the cost of care, and access to care?. Health Care Delivery in the United States, now in a thoroughly updated and revised 9th edition, discusses these and other core issues in the field. Under the editorship of Dr. Kovner and with the addition of Dr. James Knickman, Senior VP of Evaluation, Robert Wood Johnson Foundation, leading thinkers and practitioners in the field examine how medical knowledge creates new healthcare services. Emerging and recurrent issues from wide perspectives of health policy and public health are also discussed. With an easy to understand format and a focus on the major core challenges of the delivery of health care, this is the textbook of choice for course work in health care, the reference for administrators and policy makers, and the standard for in-service training programs.;chapter