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 session, Del 3U.S. Government Printing Office, 1985 |
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Side 265
... DRUGS THOMAS SCARLETT , CHIEF COUNSEL GERALD F. MEYER , ASSOCIATE ... ORPHAN PRODUCTS DEVELOPMENT RICHARD RONK , DEPUTY DIRECTOR , CENTER FOR FOOD ... Drug Administration Food and Drug Administration Printed for the use of the Committee on ...
... DRUGS THOMAS SCARLETT , CHIEF COUNSEL GERALD F. MEYER , ASSOCIATE ... ORPHAN PRODUCTS DEVELOPMENT RICHARD RONK , DEPUTY DIRECTOR , CENTER FOR FOOD ... Drug Administration Food and Drug Administration Printed for the use of the Committee on ...
Side 267
... orphan drugs , and these are drugs for minor species of animals . And I have mentioned in my testimony one of the areas that we were particularly interested in and that is dealing with aquacul- ture . One of the concerns we have in the ...
... orphan drugs , and these are drugs for minor species of animals . And I have mentioned in my testimony one of the areas that we were particularly interested in and that is dealing with aquacul- ture . One of the concerns we have in the ...
Side 268
... ORPHAN DRUGS AND MEDICAL DEVICES Orphan Sponsor designa- commit- tions Drug and device marketing applications ments Submitted Approved 3 6 55362 433533 0016 2 16 23 15 14 1 ( 13 ) 4 5 5 Exclusivity Grant approval applications ...
... ORPHAN DRUGS AND MEDICAL DEVICES Orphan Sponsor designa- commit- tions Drug and device marketing applications ments Submitted Approved 3 6 55362 433533 0016 2 16 23 15 14 1 ( 13 ) 4 5 5 Exclusivity Grant approval applications ...
Side 269
... ORPHAN DRUGS Mr. WHITTEN . Just reconsider it , but go ahead with what we al- ready stood for . Tell us why it is you thought our chief interest in orphan drugs was for minor species of animals as against human beings . Dr. YOUNG . We ...
... ORPHAN DRUGS Mr. WHITTEN . Just reconsider it , but go ahead with what we al- ready stood for . Tell us why it is you thought our chief interest in orphan drugs was for minor species of animals as against human beings . Dr. YOUNG . We ...
Side 270
... orphan drug program and thanks to your Subcommittee we have been able to fund 19 grants . We feel that at least half of them have the poten- tial for yielding new orphan drugs for the market . USER CHARGES Mr. WHITTEN . The charge of ...
... orphan drug program and thanks to your Subcommittee we have been able to fund 19 grants . We feel that at least half of them have the poten- tial for yielding new orphan drugs for the market . USER CHARGES Mr. WHITTEN . The charge of ...
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Act 21 USC action addition Agency amended antibody antibody test approved audit blood Center CFTC clinical Commission's Committee Commodity Exchange Act Commodity Futures Trading commodity pool compliance conducted contract market Cosmetic Act 21 costs CPOs Delaney Clause Director Division donors Drug Administration drug applications effective enforcement evaluation Federal Food fees filed fiscal year 1984 Food and Drug funds futures contracts Futures Trading Commission HTLV HTLV-III antibody implement increase investigations issued labeling leverage transaction listed drug Market Surveillance Methyl Bromide monitoring National Futures Association NFA's NPRM Office orphan drugs orphan products patent percent person personnel PHILLIPS plasma proposed rare diseases recommendations reduced registration regulations regulatory request responsibility result rules safety Services staff staff-years studies submitted subsection Tegretol tion treatment virus Western blot WHITTEN
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Side 81 - 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...
Side 592 - 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...
Side 83 - 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.
Side 592 - ... that no residue of the additive will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (f) and (g)) in any edible portion of such animal after slaughter or in any food yielded by or derived from the living animal- or SBC.
Side 95 - 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...
Side 322 - 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...
Side 94 - Commission be modified or set aside in whole or in part. A copy of...
Side 91 - Service may be made by leaving a copy of the process in the office of the...
Side 83 - 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...
Side 101 - ... 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...