...FOUNTAIN. The IND regulations, as your statement mentions, requires sponsors to report promptly to FDA any findings associated with use of the drug that may suggest significant hazards, side effects and precautions pertinent to the safety of the drug. In your opinion, has the firm met...

...FOUNTAIN. The IND regulations, as your statement mentions, requires sponsors to report promptly to FDA any findings associated with use of the drug that may suggest significant hazards, side effects and precautions pertinent to the safety of the drug. In your opinion, has the firm met...

...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...

..."accurate progress reports of the Investigations and significant findings;" Investigate and report to FDA "any findings associated with use of the drug that may suggest significant hazards. . . pertinent to the safety of the drug." Proposed new IMP regulations (48 FR ?6720; June 9, 1983)...

...promptly investigate and report to the FDA and to all investigators any findings associated with the use of the drug that may suggest significant hazards,...effects, and precautions pertinent to the safety of DMSO. Eye changes in the scleroderma patients clearly fall within this definition. It is possible that...

...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, side-effects, and precautions pertinent to the safety of the drug. If the finding is alarming, it shall...

...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...

...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 distribu tion of the drug for...

...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....

...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....