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" The sponsor shall promptly investigate and report to the Food and Drug Administration and to all investigators any findings associated with use of the drug that may suggest significant hazards, contraindications, sideeffects, and precautions pertinent... "
Drug Safety - Page 888
by United States. Congress. House. Committee on Government Operations - 1964
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1987 - 996 pages
...written request copies of these reports shall be submitted to the Food and Drug Administration. (8) The sponsor shall promptly investigate and report...may suggest significant hazards, contraindications, side-effects, and precautions pertinent to the safety of the drug. If the finding is alarming it shall...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1981 - 1252 pages
...written request copies of these reports shall be submitted to the Food and Drug Administration. (6) The sponsor shall promptly investigate and report...may suggest significant hazards, contraindications, sideeffects, and precautions pertinent to the safety of the drug. If the finding is alarming it shall...
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The Code of Federal Regulations of the United States of America

Administrative law - 1969 - 668 pages
...by scientific training and experience to evaluate information obtained from the investigation, and shall promptly investigate and report to the Food...use of the drug that may suggest significant hazards pertinent to the safety of the drug. (iii) Shall not unduly prolong distribution of the drug for investigational...
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The Code of Federal Regulations of the United States of America

Administrative law - 1986 - 792 pages
...by scientific training and experience to evaluate information obtained from the investigation, and shall promptly investigate and report to the Food...investigators any findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the new animal drug....
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The Code of Federal Regulations of the United States of America

Administrative law - 1992 - 744 pages
...by scientific training and experience to evaluate information obtained from the Investigation, and shall promptly investigate and report to the Food...investigators any findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the new animal drug....
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1977 - 1080 pages
...the Pood and Drug Administration. (0) The sponsor shall promptly Investigate and report to the Pood and Drug Administration and to all investigators any...may suggest significant hazards, contraindications, side-effects, and precautions pertinent to the safety of the drug. If the finding is alarming it shall...
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Code of Federal Regulations: Containing a Codification of Documents of ...

Administrative law - 1981 - 738 pages
...information obtained from the investigation, and shall promptly investigate and report to the Pood and Drug Administration and to all investigators any findings associated with use of the new animal drug that may suggest significant hazards pertinent to the safety of the new animal drug....
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Drug Industry Act of 1962, Hearings ... 87-2 ... June 19, 20, 21, 22, August ...

United States. Congress. House. Interstate and Foreign Commerce - 1962 - 732 pages
...these reports shall be submitted to the Food and Drug Administration. (6) The sponsor shall immediately report to the Food and Drug Administration and to...findings associated with use of the drug that may suggest hazards, contraindications, side effects, and precautions pertinent to the safety of the drug. (7)...
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Drug Industry Act of 1962: Hearings ... Eighty-seventh Congress, Second ...

United States. Congress. House. Committee on Interstate and Foreign Commerce - Cosmetics - 1962 - 734 pages
...reports shall be submitted to the Food and Drug Administration. (6) The sponsor shall immediately rejwrt to the Food and Drug Administration and to all investigators...findings associated with use of the drug that may suggest hazards, contraindications, side effects, and precautions pertinent to the safety of the drug. (7)...
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Competitive Problems in the Drug Industry, Volume 14

United States. Congress. Senate. Select Committee on Small Business. Subcommittee on Monopoly - Pharmaceutical industry - 1969 - 460 pages
...the Food and Drug Administration. (6) The sponsor shall promptly investigate and report to the Pood and Drug Administration and to all investigators any findings associated with use ef the drug that may suggest significant hazards, contraindications, side-effects, and precautions...
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