Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997
Author: United States. Congress. House. Committee on Commerce
Publisher:
Published: 1997
Total Pages: 144
ISBN-13:
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Author: United States. Congress. House. Committee on Commerce
Publisher:
Published: 1997
Total Pages: 144
ISBN-13:
DOWNLOAD EBOOKAuthor: Institute of Medicine
Publisher: National Academies Press
Published: 2007-03-27
Total Pages: 347
ISBN-13: 0309103045
DOWNLOAD EBOOKIn 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
Publisher: National Academies Press
Published: 2017-09-28
Total Pages: 483
ISBN-13: 0309459575
DOWNLOAD EBOOKDrug 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:
Publisher:
Published: 2004
Total Pages: 556
ISBN-13:
DOWNLOAD EBOOKAuthor: United States. Congress. House. Committee on Commerce
Publisher:
Published:
Total Pages: 624
ISBN-13:
DOWNLOAD EBOOKAuthor: United States. Congress. House. Committee on Commerce
Publisher:
Published: 1999
Total Pages: 136
ISBN-13:
DOWNLOAD EBOOKAuthor: Institute of Medicine
Publisher: National Academies Press
Published: 2011-04-03
Total Pages: 442
ISBN-13: 0309158060
DOWNLOAD EBOOKRare 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: Richard Abood
Publisher: Jones & Bartlett Learning
Published: 2011
Total Pages: 474
ISBN-13: 0763781290
DOWNLOAD EBOOKThe 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.
Author: ADAM I. MUCHMORE
Publisher:
Published: 2021-03-14
Total Pages: 734
ISBN-13: 9781531004453
DOWNLOAD EBOOKAuthor: United States. General Accounting Office
Publisher: DIANE Publishing
Published: 2003
Total Pages: 63
ISBN-13: 1428942831
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