Agriculture, rural development, and related agencies appropriations for 1986: hearings before a subcommittee of the Committee on Appropriations, House of Representatives, Ninety-ninth Congress, first sessionU.S. Government Printing Office, 1986 |
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Términos y frases comunes
Act 21 USC action activities addition Agency animal drugs antibiotic antibody appropriate approved associated audit bacteria blood products budget Campylobacter Center CFTC clinical Commission Commission's Committee Commodity Exchange Act compliance conducted Continue contracts Cosmetic Act 21 costs Delaney Clause Director donors Drug Administration Drug Applications drug products effective enforcement evaluation FDA's Federal Food fees fiscal food additive Food and Drug Full-time Equivalent funds futures contracts Futures Trading HTLV-III implement increase investigations issues labeling laboratory manufacturers medical devices monitoring NPRM Office operating options orphan drugs orphan products patients percent pertussis pesticides PHILLIPS plasma plasmids potential proposed rare diseases reduce registration regulations regulatory request rule safety Salmonella samples Section Services sponsors staff staff-years studies submitted subsection surveillance tetracycline tion toxicity treatment user charges vaccines WHITTEN
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Página 85 - The act, omission, or failure of any official, agent, or other person acting for any individual, association, partnership, corporation, or trust within the scope of his employment or office shall be deemed the act, omission, or failure of such individual, association, partnership, corporation, or trust, as well as of such official, agent, or other person. The words "interstate commerce...
Página 586 - Secretary (A) fails to establish that the proposed use of the food additive under the conditions of use to be specified in the regulation will be safe: provided that no additive shall be deemed to be safe if it is found to induce cancer when ingested by man or animal or if it is found, after tests which are appropriate for the evaluation of the safety of food additives, to induce cancer in man or animal...
Página 87 - For the purpose of any such investigation, or any other proceeding under this title, any member of the Commission or any officer designated by it is empowered to administer oaths and affirmations, subpoena witnesses, compel their attendance, take evidence, and require the production of any books, papers, correspondence, memoranda, or other records which the Commission deems relevant or material to the inquiry.
Página 88 - Whenever it shall appear to the Commission that any person has engaged or is about to engage in any act or practice constituting a violation of any provision...
Página 99 - Code. (2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds...
Página 328 - 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...
Página 586 - ... will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to...
Página 105 - ... or any rule or regulation thereunder or any undertaking contained in a registration statement as provided in subsection (d) of Section 15 of this title, which statement was at the time and in the light of the circumstances under which it was made false or misleading with respect to any material fact...
Página 736 - The generic drugs program took on special importance with the passage of the "Drug Price Competition and Patent Term Restoration Act of 1984...
Página 87 - The Commission may, in its discretion, make such investigations as it deems necessary to determine whether any person has violated or is about to violate...