FDA's Generic Drug Approval Process: Hearings Before the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, House of Representatives, One Hundred First Congress, First Session, Part 5U.S. Government Printing Office, 1989 |
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Action Plan August Agency American Therapeutics Amitriptyline ANDA's Voluntarily Withdrawn Ashok Patel ATI's audits August 29 Barr Laboratories Barr's believe bioequivalence biostudy BLILEY Bolar Brancato brand name Capsules Chairman Charles Chang client Clonidine Clorazepate Clorazepate Dipotassium committee communications consultant corporate counsel Diazepam Dilip Shah DINGELL Director DISTRICT OF MARYLAND Division documents Drug Administration drug applications drug companies drug firms drug industry drug manufacturers drug products Dyazide false statements FDA employees FDA-Relations Action Plan FDA's Finelli FIRM ANDA Food and Drug fraud gratuities Hill and Knowlton Hydrochloride Tablets Hydrochlorothiazide involved issues JORDAN Kip Schwartz Kletch LENT manufacturing practices MCMILLAN MICHELS NAVAZIO Norris Oxazepam pharmaceutical Pharmagen PharmaKinetics Plan August 29 problems Quad recall request Rockville samples Sturm submitted Superpharm testimony tion Trazodone Triamterene U.S. Attorney Vegesna Vitarine VOGEL WILLCOX withdraw Withdrawn Since 5/1/89 WYDEN York