Drug Safety, Parts 1-2U.S. Government Printing Office, 1964 |
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Page 174
... GRAY . The burden of proof is now on the manufacturer , if there is reasonable question of safety ? Mr. LARRICK . Yes . As it used to be , we assumed the burden of proof and if we couldn't prove it was dangerous , we couldn't take it ...
... GRAY . The burden of proof is now on the manufacturer , if there is reasonable question of safety ? Mr. LARRICK . Yes . As it used to be , we assumed the burden of proof and if we couldn't prove it was dangerous , we couldn't take it ...
Page 184
... Gray ? There may be one or two followup Mr. GRAY . I can appreciate , Mr. Larrick , that under the 1938 law , you did not necessarily have authority to pass on the effectiveness of drugs . But in effect , did you not have the same kind ...
... Gray ? There may be one or two followup Mr. GRAY . I can appreciate , Mr. Larrick , that under the 1938 law , you did not necessarily have authority to pass on the effectiveness of drugs . But in effect , did you not have the same kind ...
Page 185
... GRAY . You could not force them to comply with the suggestion ? Mr. LARRICK . That is right . That is the difference between the old law and the new . For example , in the case of the drug that has been mentioned so much in the paper ...
... GRAY . You could not force them to comply with the suggestion ? Mr. LARRICK . That is right . That is the difference between the old law and the new . For example , in the case of the drug that has been mentioned so much in the paper ...
Page 186
... GRAY . This was on approval of drugs ? Mr. LARRICK . That is right . Mr. GRAY . Did you not have the same situation on the withdrawal of a drug ? Would you not also ask for a hearing , under the old law , on withdrawal of a drug and go ...
... GRAY . This was on approval of drugs ? Mr. LARRICK . That is right . Mr. GRAY . Did you not have the same situation on the withdrawal of a drug ? Would you not also ask for a hearing , under the old law , on withdrawal of a drug and go ...
Page 187
... GRAY . How often did you go through that hearing procedure during that period of time ? Mr. GOODRICH . Very few times . We took several drugs off the market as you know by saying " Unless this drug is withdrawn or un- less this warning ...
... GRAY . How often did you go through that hearing procedure during that period of time ? Mr. GOODRICH . Very few times . We took several drugs off the market as you know by saying " Unless this drug is withdrawn or un- less this warning ...
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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.