FDA's Generic Drug Enforcement and Approval Process: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred Second Congress, First Session, March 7 and June 5, 1991, Volume 4
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Oversight and Investigations
U.S. Government Printing Office, Jan 1, 1992 - Generic drugs - 587 pages
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action agency Alert List Alra Laboratories ANDA ANDA approvals ANDA's approval process Barr Barr Laboratories Benjamin Bhutani bioequivalence Bleyendaal Bliley Bruederle CDER Center for Drug CGMP Chair Chairman chemistry review Chesemore Chicago District Office committee companies compliance conjugated estrogens consultants correct dated deficiencies Dingell Director Division documents Drug Administration drug applications drug approval Drug Evaluation drug industry drug products employees facility FDA's firm firm's Food and Drug fraud Fujisawa Haloperidol initial injunction inspection Inspector investigation issues Kapoor Kibbe Kopf labeling Lactulose Lyphomed manufacturing practices meeting Melrose Park Meyer Michels Mlecko Morton Grove MY-K Mylan operations pentamidine personnel Pharmaceutical problems procedures questions regulatory letter requested requirements response retaliation review chemists review process Rowland Sittig staff Stojak Subcommittee submission submitted syrup tablets Tambi Vincristine violations Wyden Wyeth-Ayerst Zarembo