FDA Proposals to Ease Restrictions on the Use and Sale of Experimental Drugs: Hearing Before a Subcommittee of the Committee on Government Operations, House of Representatives, One Hundredth Congress, First Session, April 29, 1987, Volume 4U.S. Government Printing Office, 1987 - 327 pages |
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... Institutes of Health , accompanied by Dr. William Friedewald , Associate Director for Disease Prevention , Office of the Director ; Dr. Maureen W. Myers , Chief , AIDS Treatment Branch , National Institute for Allergy and Infectious Dis ...
... Institutes of Health , accompanied by Dr. William Friedewald , Associate Director for Disease Prevention , Office of the Director ; Dr. Maureen W. Myers , Chief , AIDS Treatment Branch , National Institute for Allergy and Infectious Dis ...
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... Institutes of Health ; and prestigious scien- tists and clinicians from important medical education , research , and treatment institutions . Before we take testimony from our first panel , the Chair wishes to state that the Office of ...
... Institutes of Health ; and prestigious scien- tists and clinicians from important medical education , research , and treatment institutions . Before we take testimony from our first panel , the Chair wishes to state that the Office of ...
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... Institutes of Health . I would ask the following individuals to please approach the witness table : Dr. William F. Raub ... Institute for Allergy and Infectious Diseases ; and Dr. Charles R. McCarthy , Office for Protection from Research ...
... Institutes of Health . I would ask the following individuals to please approach the witness table : Dr. William F. Raub ... Institute for Allergy and Infectious Diseases ; and Dr. Charles R. McCarthy , Office for Protection from Research ...
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... INSTITUTES OF HEALTH , ACCOMPANIED BY DR . WIL- LIAM FRIEDEWALD , ASSOCIATE DIRECTOR FOR DISEASE PRE- VENTION , OFFICE OF THE DIRECTOR ; DR . MAUREEN W. MYERS , CHIEF , AIDS TREATMENT BRANCH , NATIONAL INSTITUTE FOR ALLERGY AND ...
... INSTITUTES OF HEALTH , ACCOMPANIED BY DR . WIL- LIAM FRIEDEWALD , ASSOCIATE DIRECTOR FOR DISEASE PRE- VENTION , OFFICE OF THE DIRECTOR ; DR . MAUREEN W. MYERS , CHIEF , AIDS TREATMENT BRANCH , NATIONAL INSTITUTE FOR ALLERGY AND ...
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... Institute of Allergy and In- fectious Diseases , or NIAID , is actively involved in developing drugs for patients with terminal conditions . Is that correct ? Dr. MYERS . Yes , Mr. Chairman , that is true . Mr. WEISS . In your judgment ...
... Institute of Allergy and In- fectious Diseases , or NIAID , is actively involved in developing drugs for patients with terminal conditions . Is that correct ? Dr. MYERS . Yes , Mr. Chairman , that is true . Mr. WEISS . In your judgment ...
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Expressions et termes fréquents
adequate agency AIDS approval with due April April 22 authority cancer Chairman clinical investigation commercial concern CONGRESS THE LIBRARY controlled clinical trial criteria desperately ill patients distribution Drug Administration drug development drug for treatment due diligence evidence of safety experimental drugs FDA approval FDA's final rule Food and Drug FRIEDEWALD HUMAN SERVICES immediately life-threatening disease IND's informed consent institutional review boards investigational agents investigational drug investigational new drugs IRB review issue LIBRARY OF CONGRESS LIGHTFOOT Mary Gross MYERS orphan drug phase physician potential preamble proposed regulations proposed rule protocol or treatment pursuing marketing approval regulatory reproposal response ribavirin safety and effectiveness safety and efficacy sale of investigational satisfactory alternative drug SCARLETT serious disease sponsor studies subcommittee submitted TED WEISS therapeutic benefit toxicity treat treatment IND treatment IND/protocol treatment protocol waiver WEISS YOUNG
Fréquemment cités
Page 151 - The power of the Congress to conduct investigations is inherent in the legislative process. That power is broad. It encompasses inquiries concerning the administration of existing laws as well as proposed or possibly needed statutes. It includes surveys of defects in our social, economic or political system for the purpose of enabling the Congress to remedy them. It comprehends probes into departments of the Federal Government to expose corruption, inefficiency or waste.
Page 141 - Federal agency in implementation of these regulations (§ 1507.3) and for which, therefore, neither an environmental assessment nor an environmental impact statement is required.
Page 327 - A treatment protocol containing the same information listed in paragraph (a)(l) of this section. (v) A statement of the practitioner's qualifications to use the investigational drug for the intended treatment use. (vi) The practitioner's statement of familiarity with information on the drug's safety and effectiveness derived from previous clinical and nonclinical experience with the drug. (vii) Agreement to report to FDA safety information in accordance with § 312.32. (2) A licensed practitioner...
Page 141 - Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document Received comments may be seen In the office above between 9 am and 4 pm . Monday through Friday.
Page 327 - ... explanation of why the use of the investigational drug is preferable to the use of available marketed treatments. (iii) A brief description of the criteria for patient selection. (iv) The method of administration of the drug and the dosages. (v) A description of clinical procedures, laboratory tests, or other measures to monitor the effects of the drug and to minimize risk. (2) A treatment protocol is to be supported by the following: (i) Informational brochure for supplying to each treating...
Page 74 - DEPARTMENT OF HEALTH AND HUMAN SERVICES BEFORE THE SUBCOMMITTEE ON HUMAN RESOURCES AND INTERGOVERNMENTAL RELATIONS COMMITTEE ON GOVERNMENT OPERATIONS US HOUSE OF REPRESENTATIVES JUNE 4, 1992 FOR RELEASE ONLY UPON DELIVERY Good Morning Mr.
Page 137 - Secretary's order. (i) The Secretary shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely For investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Page 142 - The intended use of the drug. (ii) An explanation of the rationale for use of the drug, including, as appro-priate, either a list of what available regimens ordinarily should be tried be-fore using the investigational drug or an explanation...
Page 82 - The drug is under investigation in a controlled clinical trial under an IND in effect for the trial, or all clinical trials have been completed; and (iv) The sponsor of the controlled clinical trial is actively pursuing marketing approval of the investigational drug with due diligence.
Page 142 - ... supplies an investigational drug to a licensed medical practitioner for purposes of a separate treatment clinical investigation shall be deemed to authorize the incorporation-by-reference of the technical information contained in the sponsor's IND into the medical practitioner's treatment IND.