A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its AmendmentsU.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1979 - Cosmetics |
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Common terms and phrases
action ADRIANI adverse reactions advertising Advisory Committee Amsterdam analgesic anesthesia angina angina pectoris approved Apter associated blastocyst BROWN of Michigan BROWN of Ohio Bureau of Drugs Chairman closure committee members corpus luteum CROUT Dalkon Shield droperidol Drug Administration efficacy endometrial endometrium evaluation Excerpta Medica Foundation experience expulsion Family Planning FDA staff FDA's Federal fentanyl Fertil Food and Drug foreign body FOUNTAIN GOLDBERG GOLDHAMMER Gynec HUTT indicated Innovar International Congress Series intra intrauterine contraceptive device intrauterine devices investigators IUD's Journal of Obstetrics labeling Lewit McNeil Laboratories meeting method months Obstetrics and Gynecology oviduct package insert Panel on Review patients pelvic pelvic inflammatory disease percent perforation physicians Planned Parenthood propranolol question rates recommended record removal safety SCHMIDT scientific Segal spiral statement sterile studies subcommittee Talk Paper THAIN Tietze tion transcript tubal uterus VANDER JAGT woman-months women
Popular passages
Page 352 - 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 352 - Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling...
Page 562 - ... when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of...
Page 788 - Congress shall file a charter in accordance with such section upon the expiration of each successive two-year period following the date of enactment of the Act establishing such advisory committee.
Page 656 - ... in some cases, that the most important complication is abnormal blood clotting which can have a fatal outcome, that the physician recognizes an obligation to discuss the potential hazards of taking the drugs with the patient, that he has available for the patient written material discussing the effectiveness and the hazards of the drugs, and that users of the oral contraceptives should notify their physicians if they notice any unusual physical disturbance or discomfort.
Page 285 - ... Law Division of the American Bar Association's Corporation, Banking, and Business Law Section. He was Chairman of the Food and Drug Law Committee of the American Bar Association's Administrative Law Section in 1965-1966. He is presently a member of the Advisory Lawyers Committee to the Food and Drug Law Institute and of the New Foods Panel of the White House Conference on Food, Nutrition and Health. Mr. Hutt has spoken and written extensively on the subjects of food and drug law, alcoholism and...
Page 37 - Chairman, that we concluded were unsafe or ineffective, we would bring similar legal action. Mr. FOUNTAIN. I have a number of questions I would like to ask, but before we finish, I want to yield to my colleagues. I think I am going to submit these questions to FDA for answers for the record. I think they...
Page 564 - Secretary finds (1) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports, in accordance with a regulation or...
Page 738 - Executive order to be kept secret in the interest of the national defense or foreign policy; (2) related solely to the internal personnel rules and practices of an agency; (3) specifically exempted from disclosure by statute; (4) trade secrets and commercial or financial information obtained from a person and privileged or confidential; (5) inter-agency or intra-agency memorandums or letters which would not be available...
Page 754 - The meetings will involve solely the internal expression of views and judgments of the members and it is essential to close the meeting or portions thereof to protect the free exchange of such views and avoid undue interference with agency or committee operations...