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action additional adverse animal application approved associated basis believe Branch Bureau of Medicine cause Chairman changes clinical combination Commissioner committee concerning considered correct course cyclizine deaths decision determine Director discussed Division dose Drug Administration drug application effect evaluation evidence experience fact final Food and Drug Fountain further give given GoLDBERG GRAY hearing hospitals human important indicated investigational drug January KELSEY labeling LARRICK lesions letter March matter meclizine medical officer meeting memorandum opinion Parnate patients percent period person pharmacologist physicians possible potassium pregnancy prepared present problem proposed question reactions reason received recommendations record referred representatives request respect responsibility SADUsk safety sent Smith sponsor staff statement studies submitted suggested summary taken tests tion treatment warning weeks
Page 1256 - As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be, concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended,...
Page 1102 - Register, to be in the public interest in connection with the performance of duties imposed on that agency by law.
Page 1305 - Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved...
Page 1315 - Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested...
Page 818 - The sponsor shall recall the unused supplies of the drug upon notification of the termination. (e) Where drugs were under clinical trial on man on or after August 10, 1962, the sponsor shall, within 30 days after these regulations become effective, submit a list of such investigational drugs, and within 120 days after such effective date shall submit to the Food and Drug Administration the completed "Notice of claimed investigational exemption for a new drug...
Page 886 - The sponsor shall promptly investigate and report to the Food and Drug Administration and to all investigators any findings associated with use of the drug that may suggest significant hazards, contraindications, sideeffects, and precautions pertinent to the safety of the drug.
Page 837 - ... program that is to be undertaken. 9. The names and a summary of the training and experience of each investigator and of the individual charged with monitoring the progress of the investigation and evaluating the evidence of safety and effectiveness of the drug as it is...
Page 837 - The scientific training and experience considered appropriate by the sponsor to qualify the Investigators as suitable experts to Investigate the safety of the drug, bearing In mind what is known about the pharmacological action of the drug and the phase of the investigational program that is to be undertaken.