Drug Industry Antitrust Act, 87-1&2 |
From inside the book
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Page 24
... means are available to determine from time to time whether that establishment continues to fulfill the requirements established under subsection ( b ) with respect to that drug . If at any time the Secretary determines that such means ...
... means are available to determine from time to time whether that establishment continues to fulfill the requirements established under subsection ( b ) with respect to that drug . If at any time the Secretary determines that such means ...
Page 32
... mean quite literally the difference between life and death . A new drug which may be unsafe to health should not be ... means are available to de- termine from time to time that the plant continues to 32 DRUG INDUSTRY ANTITRUST ACT.
... mean quite literally the difference between life and death . A new drug which may be unsafe to health should not be ... means are available to de- termine from time to time that the plant continues to 32 DRUG INDUSTRY ANTITRUST ACT.
Page 56
... mean to say , and I think I understood you to say that this was prior to clinical approval , so , therefore , is ... means that we have the development of effective new agents . Now , please understand that before any drug would be used ...
... mean to say , and I think I understood you to say that this was prior to clinical approval , so , therefore , is ... means that we have the development of effective new agents . Now , please understand that before any drug would be used ...
Page 60
... mean the physician . I mean the physician ought to tell his patient , or the patient's father in case he is a child . Dr. HUSSEY . I quite agree . Senator DIRKSEN . But , Doctor , let me point out to our chairman that that section of ...
... mean the physician . I mean the physician ought to tell his patient , or the patient's father in case he is a child . Dr. HUSSEY . I quite agree . Senator DIRKSEN . But , Doctor , let me point out to our chairman that that section of ...
Page 65
... mean : Is it relatively useful ? It means : Is it useful ? With all of your reports and if everything is backed up , do you really believe FDA could deny it because it is not efficacious ? Dr. HUSSEY . In the instance you cite , Senator ...
... mean : Is it relatively useful ? It means : Is it useful ? With all of your reports and if everything is backed up , do you really believe FDA could deny it because it is not efficacious ? Dr. HUSSEY . In the instance you cite , Senator ...
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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...