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 888by United States. Congress. House. Committee on Government Operations - 1964Full view - About this book
| 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... | |
| 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... | |
| 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... | |
| 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.... | |
| 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.... | |
| 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... | |
| 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.... | |
| 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)... | |
| 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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