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 4U.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Action Plan August Agency American Therapeutics Amitriptyline ANDA's Voluntarily Withdrawn Ashok Patel ATI's audits August 29 Barr Laboratories Barr's believe bioequivalence biostudy BLILEY Bolar Brancato brand name Capsules Chairman Charles Chang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 Food and Drug fraud gratuities Hill and Knowlton Hydrochloride Tablets Hydrochlorothiazide involved issues JORDAN Kip Schwarts Kletch LENT manufacturing practices MCMILLAN MICHELS NAVAZIO Norris Oxazepam pharmaceutical Pharmagen PharmaKinetics Plan August 29 problems Quad recall request Rockville samples Schwartz Sturm submitted Superpharm testimony tion Trazodone Triamterene U.S. Attorney Vegesna Vitarine VOGEL WILLCOX withdraw Withdrawn Since 5/1/89 WYDEN York
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Page 5 - Building, at the hour of 10 am, then and there to testify touching matters of inquiry committed to said committee; and he is not to depart without leave of said committee. Herein fail not, and make return of this summons "Witness my hand and the seal of the House of Representatives of the United States, at the city of Washington, this 23d day of January 1947. "J. PARNELL THOMAS, Chairman. "Attest: "JOHN ANDREWS, Clerk.
Page 67 - Administrator similarly cited the value of work done by the Department of Health and Human Services Office of the Inspector General and IV&V vendors at contractor sites in uncovering problems.
Page 1 - X), any committee, or any subcommittee thereof, is authorized (subject to subparagraph (2)(A) of this paragraph)— (A) to sit and act at such times and places within the United States, whether the House is in session, has recessed, or has adjourned...
Page 1 - Harrington with the clear understanding that availability of the transcript was subject to both the Rules of the House of Representatives and the Rules of the Committee on Armed Services.
Page 1 - Investigations has responsibility for oversight of agencies, departments and all programs within the jurisdiction of the full committee. The jurisdiction of the Committee on...
Page 137 - Report by the Subcommittee on Oversight and Investigations of the House Committee on Interstate and Foreign Commerce, 96th Cong., 1st Sess., at 13 (1979).
Page 60 - ... Agency procured an opinion of the Corporation Counsel on the legality of plans for townhouses in area B in connection with the Alley Dwelling Act. The Agency consulted its own counsel in this matter. If you desire additional information, please let me know. Sincerely, PHIL A. DOYLE, Executive Director. (Whereupon at 12:30 pm, the hearing was adjourned, to reconvene at the call of the Chair.) APPENDIX REPORT TO THE CONGRESS OF THE UNITED STATES BY THE COMPTROLLER GENERAL OF THE UNITED STATES JUNE...
Page 74 - ... correct violations of the Act in your facility. Your response must address comprehensively each of the violations and specific corrective actions to preclude recurrence. Include in your response steps to correct the violative products in the market that were manufactured using unapproved formulas. Finally, we request your cooperation during future inspections of your facility. In this inspection, some records were not available when requested by the investigators, but then were made available...
Page 103 - Mr. Chairman, that completes my prepared remarks. I will be> happy to attempt to answer any questions which you or other members of the subcommittee might have.
Page 36 - The Honorable John D. Dingell Chairman, Subcommittee on Oversight and Investigations US House of Representatives Washington, DC 20515 Dear Congressman Dingell: I am in receipt of your recent letter commending the assistance of Special Agent Patricia D'Orsa-DiJamco for her testimony during the hearing on "Operation Snowstorm.