Drug Industry Antitrust Act, 87-1&2 |
From inside the book
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Page 10
... efficacious as well as safe ; that advertising and promotional material contain information about a drug's efficacy and safety ; that the package inserts , which have long been regularly prepared for approval by the Food and Drug ...
... efficacious as well as safe ; that advertising and promotional material contain information about a drug's efficacy and safety ; that the package inserts , which have long been regularly prepared for approval by the Food and Drug ...
Page 23
... efficacy : Provided , That the term ' advertise- ments ' shall include all forms of advertising , whether ... efficacious in use " . ( 9 ) Section 505 ( c ) of that Act ( 21 U.S.C. 355 ( c ) ) is amended to read as follows : " ( c ) No ...
... efficacy : Provided , That the term ' advertise- ments ' shall include all forms of advertising , whether ... efficacious in use " . ( 9 ) Section 505 ( c ) of that Act ( 21 U.S.C. 355 ( c ) ) is amended to read as follows : " ( c ) No ...
Page 45
... efficacy of drugs can proceed more fruitfully . Unfortunately , even we physicians use the word " efficacy " in a different context when we compare drugs and when we compare drug therapy to other forms of treatment . It is not unusual ...
... efficacy of drugs can proceed more fruitfully . Unfortunately , even we physicians use the word " efficacy " in a different context when we compare drugs and when we compare drug therapy to other forms of treatment . It is not unusual ...
Page 46
... efficacy of a drug for the treatment of a particular condition be established . Moreover , and equally important , we know that many of the drugs we use today in treating particular conditions . were never originally intended for such ...
... efficacy of a drug for the treatment of a particular condition be established . Moreover , and equally important , we know that many of the drugs we use today in treating particular conditions . were never originally intended for such ...
Page 51
... efficacious ? Dr. HUSSEY . The point here is that the decision on efficacy is some- thing that is subject continually to revision and even to redirection . On the matter of revision , a drug proposed for a new drug application to the ...
... efficacious ? Dr. HUSSEY . The point here is that the decision on efficacy is some- thing that is subject continually to revision and even to redirection . On the matter of revision , a drug proposed for a new drug application to the ...
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Common terms and phrases
agency agents American Medical Association amphetamine antibiotics Betamethasone bill Board of Trustees CELESTONE Chairman chemical CHERKASKY CHUMBRIS claims clinical committee corticosteroids Council Acceptance council on drugs diabetes direct mail doctors dosage doses Drug Administration drug application drug companies drug industry Education efficacy Estes Kefauver ethical drug manufacturer evaluation exhibit experience fact FINLAND firms FLURRY Food and Drug gammanym GOODMAN Health hospital House of Delegates HOWARD HUSSEY increase insulin JAMA laboratory LARRICK LASAGNA medical advertising medical journals medical profession medicine meprobamate nonproprietary names official name patients percent Pfizer phenformin physicians practice prescribe prescription present problem promotion proposed question recommended require response RICHMOND safety salicylamide scientific seal of acceptance Secretary selling Senator HRUSKA Senator KEFAUVER side effects standards statement tablets testing therapeutic therapy tion toxicity trade name WALLACE
Popular passages
Page 295 - new drug" means — (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a "new drug...
Page 62 - Secretary's order. (i) The Secretary Shall promulgate regulations for exempting from the operation of the foregoing subsections of this section drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.
Page 521 - Chairman, Subcommittee on Antitrust and Monopoly, Committee on the Judiciary, United...
Page 22 - An Act to protect trade and commerce against unlawful restraints and monopolies...
Page 886 - 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...
Page 13 - To promote the progress of science and useful arts, by securing, for limited times, to authors and inventors the exclusive rights to their respective writings and discoveries; 9 To constitute tribunals inferior to the Supreme Court; 10.
Page 44 - These include the American College of Physicians, the American College of Surgeons, the American Dental Association, the American Hospital Association, and the American Medical Association.
Page 27 - The judgment of the court affirming or setting aside, in whole or in part, any action of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of Title 28, United States Code.
Page 904 - ... (n) In the case of any prescription drug distributed or offered for sale in any 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 907 - Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated...