Drug Safety, Parts 1-2U.S. Government Printing Office, 1964 |
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Page 51
... studies and experience with the drug as follows : a . Adequate information about the preclinical investigations , including studies made on laboratory animals , on the basis of which the sponsor has concluded that it is reasonably safe ...
... studies and experience with the drug as follows : a . Adequate information about the preclinical investigations , including studies made on laboratory animals , on the basis of which the sponsor has concluded that it is reasonably safe ...
Page 59
... studies or animal tests and that the shipment of the new drug will actually be used for laboratory studies or animal testing . ( 3 ) The person who introduced such shipment or who delivered the drug for introduction into interstate ...
... studies or animal tests and that the shipment of the new drug will actually be used for laboratory studies or animal testing . ( 3 ) The person who introduced such shipment or who delivered the drug for introduction into interstate ...
Page 71
... studies made on laboratory animals , in which the methods used and the results obtained are clearly set forth . Such information should include identification of the person who conducted each investigation , a statement of where the ...
... studies made on laboratory animals , in which the methods used and the results obtained are clearly set forth . Such information should include identification of the person who conducted each investigation , a statement of where the ...
Page 73
... studies of the stability of the drug , including information showing the suitability of the analytical methods used . Describe any additional stability studies underway or contem- plated . Stability data should be submitted for any new ...
... studies of the stability of the drug , including information showing the suitability of the analytical methods used . Describe any additional stability studies underway or contem- plated . Stability data should be submitted for any new ...
Page 78
... studies , investigations , and tests conducted by the applicant or reported to him by any person , or reports in the scientific literature that are available to him , involving the drug that is the subject of the application or any ...
... studies , investigations , and tests conducted by the applicant or reported to him by any person , or reports in the scientific literature that are available to him , involving the drug that is the subject of the application or any ...
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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.