Author : Donald O. Beers
Release : 1995
Genre : Law
Kind : eBook
Book Rating : 574/5 ( reviews)

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Book Synopsis Generic and Innovator Drugs by : Donald O. Beers

Download or read book Generic and Innovator Drugs written by Donald O. Beers. This book was released on 1995. Available in PDF, EPUB and Kindle. Book excerpt: 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