Drug Industry Antitrust Act, 87-1&2

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Page 291 - new drug" means — (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Page 58 - 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 517 - Chairman, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, United...
Page 18 - An Act to protect trade and commerce against unlawful restraints and monopolies...
Page 882 - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions...
Page 9 - To promote the progress of science and useful arts, by securing, for limited times, to authors and inventors the exclusive rights to their respective writings and discoveries; 9 To constitute tribunals inferior to the Supreme Court; 10.
Page 40 - These include the American College of Physicians, the American College of Surgeons, the American Dental Association, the American Hospital Association, and the American Medical Association.
Page 23 - The judgment of the court affirming or setting aside, in whole or in part, any action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of Title 28, United States Code.
Page 900 - ... (n) In the case of any prescription drug distributed or offered for sale in any State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor...
Page 903 - 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, evaluated...

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