Drug Regulation Reform Act of 1978: Hearings Before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-fifth Congress, Second Session, on H.R. 11611 (and All Other Similar and Identical Bills).U.S. Government Printing Office, 1978 - Drugs |
Common terms and phrases
administrative advisory committee amended application for licensure approval assure bioavailability clinical investigations comply conduct Controlled Substances Act Cosmetic Act counterfeit drug court dispensed distribution drug development drug entity contained drug product license drug products eligible Drug Regulation Reform effective entities and drug entity or drug evaluate exemption export permit FD&C Act FDA's Federal Food Federal Trade Commission filed guidelines hearing human participants identification labeling illness or injury information labeling inspection issuance licensed under subpart manufactured manufacturing practices ment obtain Panel paragraph patient person petition pharmacist practitioner prescribed prescription drug product procedures proceedings promotion labeling proposed protocol public health pursuant regarding registration Regulation Reform Act required under section revocation revoke safety scientific Secre Secretary determines section 127 section 505 specific sponsor standards of identity submitted subsection f suspend tary tion United United States Code United States Pharmacopeia violation
Popular passages
Page 538 - 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 136 - ... (4) Complaints, orders and other process and papers of the board, its member, agent or agency, may be served either personally or by registered mail or by telegraph or by leaving a copy thereof at the principal office or place of business of the person required to be served.
Page 121 - ... (b) In any proceeding for criminal contempt for violation of an injunction or restraining order issued under this section, which violation also constitutes a violation of this Act, trial shall be by the court or, upon demand of the accused, by a jury.
Page 121 - ... if such person acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a drug being a counterfeit drug, or for having violated section...
Page 184 - Except as otherwise expressly provided, whenever in this Act an amendment or repeal is expressed In terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Internal Revenue Code of 1954.
Page 380 - Act if it (1) accords to the specifications of the foreign purchaser, (2) is not in conflict with the laws of the country to which it is intended for export, and (3) is labeled on the outside of the shipping package to show that it is intended for export.
Page 185 - ... 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 121 - Section 9860 (b), which guaranty or undertaking is false; except by a person who relied on a guaranty or undertaking to the same effect signed by, and containing the name and address of the person residing in the...
Page 321 - Adjudicative facts are the facts about the parties and their activities, businesses, and properties. Adjudicative facts usually answer the questions of who did what, where, when, how, why, with what motive or intent; adjudicative facts are roughly the kind of facts that go to a jury in a jury case. Legislative facts do not usually concern the immediate parties but are general facts which help the tribunal decide questions of law and policy and discretion.
Page 440 - ... (2) The Administrator may, after consultation with the Attorney General and the Chairman of the Federal Trade Commission...