Drug Price Competition and Patent Term Restoration Act of 1984 PDF Download
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Author: United States. Congress. Senate. Committee on Labor and Human Resources
Publisher:
ISBN:
Category : Administrative procedure
Languages : en
Pages : 474
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Book Description
Author: United States. Congress. Senate. Committee on Labor and Human Resources
Publisher:
ISBN:
Category : Administrative procedure
Languages : en
Pages : 474
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Book Description
Author:
Publisher: U.S. Government Printing Office
ISBN:
Category : Business & Economics
Languages : en
Pages : 94
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Book Description
Author: Allan M. Fox
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 570
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Book Description
Author: Anna Cook
Publisher:
ISBN: 9780788173516
Category :
Languages : en
Pages : 75
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Book Description
Examines the extent to which competition from generic drugs has increased since 1984, when the Drug Price Competition & Patent Term Restoration Act (also known as the Hatch-Waxman Act) created an abbreviated approval process for generic prescription drugs & at the same time extended patent terms for innovator drugs. Also analyzes how that competition has affected the returns from developing a drug. Contents: the effect of managed care on the pharmaceutical market; pricing & competition in the pharmaceutical market; & the effects of the Hatch-Waxman act on the returns from innovation. Charts & tables.
Author: United States. Congress. Senate. Committee on Health, Education, Labor, and Pensions
Publisher:
ISBN:
Category : Drug accessibility
Languages : en
Pages : 68
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Book Description
Author: Landmark Publications
Publisher: Independently Published
ISBN: 9781521386521
Category : Law
Languages : en
Pages : 514
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Book Description
THIS CASEBOOK contains a selection of U. S. Court of Appeals decisions that analyze, discuss and resolve patent disputes stemming from New Drug Applications filed with the Food and Drug Administration. The selection of decisions spans from 2014 to the date of publication. The Food, Drug, and Cosmetic Act ("FDCA") regulates the marketing and sale of prescription drugs in the United States. Under the FDCA, a manufacturer must obtain approval from the United States Food and Drug Administration ("FDA") before marketing a new drug. As part of a new drug application, the manufacturer must submit a proposed package insert, commonly called the "drug label," that sets out the drug's medical uses ("indications") and health risks. "To obtain FDA approval, drug companies generally must submit evidence from clinical trials and other testing that evaluate the drug's risks and benefits and demonstrate that it is safe and effective for all of the indications 'prescribed, recommended, or suggested' on the drug's label." The FDA's approval of a new drug application is conditioned on its approval of the exact text of the drug label. With the Drug Price Competition and Patent Term Restoration Act, 98 Stat. 1585, as amended, known as the Hatch-Waxman Act, Congress "attempted to balance the goal of 'mak[ing] available more low cost generic drugs' with the value of patent monopolies in incentivizing beneficial pharmaceutical advancement." King Drug Co. v. SmithKline Beecham Corp., 791 F.3d 388, 394 (3d Cir. 2015) (alteration in original) (quoting H.R. Rep. No. 98-857, pt. 1, at 14-15 (1984)), cert. denied, 137 S. Ct. 446 (2016). "The Act seeks to accomplish this purpose, in part, by encouraging 'manufacturers of generic drugs . . . to challenge weak or invalid patents on brand name drugs so consumers can enjoy lower drug prices.'" Id. (alteration in original) (quoting S. Rep. No. 107-167, at 4 (2002)).
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
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Book Description
Author: United States. President (1981-1989 : Reagan)
Publisher:
ISBN:
Category : International relations
Languages : en
Pages : 8
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Book Description
Author: Robin Feldman
Publisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
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Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author: Donald O. Beers
Publisher: Wolters Kluwer
ISBN: 1454836091
Category : Law
Languages : en
Pages : 2154
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Book Description
Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.
