A Legislative History of the Federal Food, Drug, and Cosmetic Act and Its AmendmentsU.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration, 1979 |
From inside the book
Results 1-5 of 100
Page 8
... agency's organization , policies , and procedures . While we may examine FDA's administrative performance criti- cally at times , I want to assure you gentlemen representing the agency that our criticism is intended to be constructive ...
... agency's organization , policies , and procedures . While we may examine FDA's administrative performance criti- cally at times , I want to assure you gentlemen representing the agency that our criticism is intended to be constructive ...
Page 9
... agencies it has created actually have all of the legal and administrative and scientific tools and resources they ... agency meet its grave responsi- bility to protect the health of the American people . Thank you , Mr. Chairman . Mr ...
... agencies it has created actually have all of the legal and administrative and scientific tools and resources they ... agency meet its grave responsi- bility to protect the health of the American people . Thank you , Mr. Chairman . Mr ...
Page 13
... agency The laws on which FDA's authority rests are primarily regulatory in nature and by their very essence make FDA a law enforcement agency . However , be- cause the areas of human activity that FDA regulates are characterized by high ...
... agency The laws on which FDA's authority rests are primarily regulatory in nature and by their very essence make FDA a law enforcement agency . However , be- cause the areas of human activity that FDA regulates are characterized by high ...
Page 14
... agency has , nonetheless , met with significant success , and it is fair to say that few regulatory agencies of the Federal Government can boast of having over a half century's record of more vigorous , effective , and fair enforcement ...
... agency has , nonetheless , met with significant success , and it is fair to say that few regulatory agencies of the Federal Government can boast of having over a half century's record of more vigorous , effective , and fair enforcement ...
Page 15
... agency suffered reductions in staff because of inadequate financial resources . By 1955 , FDA had a budget of $ 5.5 million . APPROPRIATIONS 1938-1964 MILLIONS $ 40 30 FIRST CAC STUDY 20 10 0 1938 45 50 55 57 FISCAL YEARS 60 64 CHART ...
... agency suffered reductions in staff because of inadequate financial resources . By 1955 , FDA had a budget of $ 5.5 million . APPROPRIATIONS 1938-1964 MILLIONS $ 40 30 FIRST CAC STUDY 20 10 0 1938 45 50 55 57 FISCAL YEARS 60 64 CHART ...
Other editions - View all
Common terms and phrases
52 Stat additional adequate adverse drug reactions adverse reactions agency animal tests animals antibiotic approved Association batch Chairman changes chart chemical claimed investigational exemption clinical investigations clinical trials Commissioner of Food committee contained contraindications Cosmetic Act Department of Health distribution dosage form Drug Administration Drug Amendments drug application drug establishments DRUG SAFETY drugs for investigational Education established name evaluation experience facilities FDA's Federal Food Federal Register Food and Drug FOUNTAIN GOLDBERG Government GRAY hearing examiner industry ingredient inspection investigational drug June 20 labeling laboratory LARRICK manufacturing manufacturing practice ment methods new-drug application notified operations package Packaging and labeling paragraph patients pharmaceutical physicians prescription drug procedures processing proposed regulations proprietary name Public Health records registration reports request samples scientific scientists side effects specific sponsor statement studies subcommittee submitted supplemental application tion Welfare
Popular passages
Page 120 - ... 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, or suggested in the labeling or proposed labeling...
Page 72 - State, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor...
Page 489 - Comp., p. 456), provides in part: (a) The Government shall obtain the entire right, title and interest in and to all inventions made by any Government employee (1) during working hours, or (2) with a contribution by the Government of facilities, equipment, materials, funds, or information, or of time or services of other Government employees on official duty, or (3) which bear a direct relation to or are made in consequence of the official duties of the inventor.
Page 43 - ... 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 120 - 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 329 - ... 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.
Page 44 - Labeling on or within the package from which the drug is to be dispensed bears adequate information for its use, including indications, effects, dosages, routes, methods, and frequency and duration of administration, and any relevant hazards, contraindications, side effects, and precautions under which practitioners licensed by law to administer the drug can use the drug safely and for the purposes for which it is intended, including all purposes for which it is advertised or represented...
Page 131 - ... products conform to appropriate standards of identity, strength, quality, and purity. Laboratory controls shall include...
Page 99 - Part 132, that engage in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs...
Page 114 - ... in sufficient detail to permit evaluation of the adequacy of the described methods of manufacture, processing, and packing and the described facilities and controls to determine and preserve the identity, strength, quality, and purity of the drug: a.