Drug Safety, Parts 1-2U.S. Government Printing Office, 1964 |
From inside the book
Results 1-5 of 99
Page 47
... animal tests only shall be exempt from section 505 ( a ) of the act if it is labeled : " Caution : New drug - Limited by Federal ( or United States ) law to laboratory research and tests on animals . Not for human use . " No animals ...
... animal tests only shall be exempt from section 505 ( a ) of the act if it is labeled : " Caution : New drug - Limited by Federal ( or United States ) law to laboratory research and tests on animals . Not for human use . " No animals ...
Page 48
... animals to assure safety . That the clinical investigations themselves be properly planned , executed by qualified investigators , and that these investigators and the FDA be kept fully informed during the progress of the investigations ...
... animals to assure safety . That the clinical investigations themselves be properly planned , executed by qualified investigators , and that these investigators and the FDA be kept fully informed during the progress of the investigations ...
Page 50
... animals was changed to make it clear that treated food animals could be used for food if there was adequate evidence that no drug residues resulted in edible tissues or in eggs or milk yielded by the animal . Labeling requirements for ...
... animals was changed to make it clear that treated food animals could be used for food if there was adequate evidence that no drug residues resulted in edible tissues or in eggs or milk yielded by the animal . Labeling requirements for ...
Page 58
... animal tests only shall be exempt from section 505 ( a ) of the act if it is labeled : " Caution : New drug - Limited by Federal ( or United States ) law to laboratory studies and tests on animals . Not for human use . " No animals used ...
... animal tests only shall be exempt from section 505 ( a ) of the act if it is labeled : " Caution : New drug - Limited by Federal ( or United States ) law to laboratory studies and tests on animals . Not for human use . " No animals used ...
Page 94
... animal biological drugs subject to licensing under the Animal , Virus , Serum , and Toxin Act administered by the Department of Agriculture . 5. Persons who use feed concentrates for feeding to their own meat animals , provided these ...
... animal biological drugs subject to licensing under the Animal , Virus , Serum , and Toxin Act administered by the Department of Agriculture . 5. Persons who use feed concentrates for feeding to their own meat animals , provided these ...
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Common terms and phrases
activities additional adequate adverse drug reactions adverse reactions advertisement Advisory agency American Medical Association animals antibiotic approved basic batch Chairman chemical chloramphenicol clinical investigations Commissioner of Food committee concerning contraindications Cosmetic Act Department of Health Drug Administration Drug Amendments drug application drug safety Education established name evaluation exemption experience facilities FDA's Federal Food Federal Register Food and Drug FOUNTAIN GOLDBERG Government GRAY hearing examiner hospitals HUSSEY ingredient inspection investigational drug labeling laboratory LARRICK manufacturing practice medical officers ment new-drug application operations package Packaging and labeling patients pharmaceutical industry Pharmaceutical Manufacturers Association pharmacology Pharmacy physicians prescription drug problems procedures processing proprietary name Public Health question records reports responsible safe samples scientific scientists side effects SMITH specific sponsor staff Stat statement studies subcommittee submitted substance supplemental application therapeutic tion toxicity Welfare
Popular passages
Page 642 - ... 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, or suggested in the labeling or proposed labeling thereof.
Page 35 - ... a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug...
Page 76 - 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 44 - States shall be exempt from the requirements of section 505 (a) of the Act if the following conditions are complied with: (1) The label of such drug bears the statement "CAUTION: NEW DRUG LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE...
Page 301 - Section l(a) and is a necessary incentive to call forth private risk capital and expense to bring the invention to the point of practical application.
Page 470 - Chairman, shall leave title to such invention in the employee, subject, however, to the reservation to the Government of a nonexclusive, irrevocable, royalty-free license in the invention with power to grant licenses for all governmental purposes...
Page 578 - Secretary finds (1) that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved...
Page 119 - ... drug, based on a fair evaluation of all material facts, is false or misleading in any particular and...
Page 121 - ... when the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.
Page 320 - ... he should retain the principal or exclusive rights for a further period of time, the government shall have the right to require the granting of a license to an applicant on a non-exclusive royalty free basis.