FDA's Generic Drug Enforcement and Approval Process
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Published: 1992
Total Pages: 604
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Published: 1992
Total Pages: 604
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Published: 1989
Total Pages: 204
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Published: 1992
Total Pages: 587
ISBN-13:
DOWNLOAD EBOOK →Author: Donald O. Beers
Publisher: Aspen Publishers
Published: 1995
Total Pages: 1280
ISBN-13: 9781567061574
DOWNLOAD EBOOK →The Fourth Edition provides a complete reference to significant developments in FDA approval requirements, including extensive coverage of innovator drugs, the drug approval process, and patent term extension. Plus, it includes the full text of relevant statutes, regulations, FDA guidelines, memoranda, correspondence, and more. This publication is an invaluable reference for drug company officials, regulatory affairs staffs, and legal counsel. This one-volume guide contains exhaustive discussions and analyses of all the major regulatory and legal actions from the 1938 FDCA grandfather clause through the Drug Price Competition and Patent Term Restoration Act of 1984 (the Waxman-Hatch Act) to Debarment and the Generic Drug Enforcement Act of 1992. Major topics covered include: FDA approval requirements Full new drug applications Abbreviated new drug applications and 'paper' ANDAs Delaying approval of competitive products Public availability of NDA data the orphan drug amendments Debarment FDA fraud policy Accelerated approvals and more
Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Health and the Environment
Publisher:
Published: 1991
Total Pages: 104
ISBN-13:
DOWNLOAD EBOOK →Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
Published: 2017-09-28
Total Pages: 483
ISBN-13: 0309459575
DOWNLOAD EBOOK →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:
Published: 1992
Total Pages: 594
ISBN-13:
DOWNLOAD EBOOK →Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
Publisher:
Published: 1989
Total Pages:
ISBN-13:
DOWNLOAD EBOOK →Author:
Publisher:
Published: 1984
Total Pages: 336
ISBN-13:
DOWNLOAD EBOOK →Accompanied by supplements.