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Pharmaceutical industry / Clinical research / Drug Price Competition and Patent Term Restoration Act / Patent law / Abbreviated New Drug Application / Generic drug / Term of patent in the United States / Food and Drug Administration / Roche Products v. Bolar Pharmaceutical / Pharmaceutical sciences / Pharmaceuticals policy / Pharmacology


Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process
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Document Date: 2010-05-14 16:26:46


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City

Bristol / Neustadt / Paris / Arlington / /

Company

Bolar Pharmaceuticals / Syntax / Delta Period / Merck / Joseph Steller co / Boston Consulting Group / Bristol-Myers Squibb / /

Continent

America / Europe / /

Country

Japan / United States / /

Event

FDA Phase / /

IndustryTerm

pharmaceutical industry / generic product / abbreviated new drug applications / chemical demonstrating / generic manufacturer / pharmaceuticals / healthcare system / research-based pharmaceutical industry / Foreign patent applications / generic products / law / pioneer products / /

Organization

House Rules Committee / Antitrust Division / Food and Drug Administration / Reagan Administration / Cabinet Council / House of Representatives / U.S. Patent and Trademark Office / U.S. Department of Commerce / Cabinet Council on Commerce and Trade / World Trade Organization / Reagan's Cabinet Council on Commerce and Trade / Pharmaceutical Manufacturers Association / Senate / U.S. Court of Appeals / U.S. Department of Justice / UN Court / US Federal Reserve / Carter's Administration / Health Subcommittee / /

Person

Bruce Lehman / Bill Baxter / David Kessler / David Pryor / William C. Cray / Henry A. Waxman / Malcolm Baldridge / Carter / Gerald J. Mossinghoff / Charles W. Johnson / Reagan / Roger E. Schecter / Estes Kefauver / John Chafee / Washington Legal Found / /

Position

Counsel / President / Chairman / Assistant Secretary / Commissioner / author / the committee / Secretary of Commerce / Commissioner of Patents and Trademarks / /

Product

Federal Food / Naprosene® / /

ProvinceOrState

Virginia / Indiana / /

PublishedMedium

Public Law / the NDA review / /

Technology

drug discovery / drug development / /

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