...Investigations will be submitted to the Food and Drug Administration. (The notice of claimed invest Igatlonal exemption may be limited to any one or more phases,...investigation. 11. A statement that the sponsor will notify the Food and Drug Administration If the investigation is discontinued, and the reason therefor. 12. A statement...

...may be limited to any one or more phases, provided the outline of the additional phase or phases is submitted before such additional phases begin. This...investigation. 11. A statement that the sponsor will notify the Food and Drug Administration if the investigation is discontinued, and the reason therefor. 12. A statement...

...may be limited to any one or more phases, provided the outline of the additional phase or phases is submitted before such additional phases begin. This...are attributable to the drug under investigation. « • • • « (12) * * • Form FD-1572 * • • » • 3. If the experimental project is to be...

...or more phases, provided the outline of the additional phase or phases Is submitted before §130.3 such additional phases begin. This does not preclude...attributable to the drug under investigation. 11. Л statement that the sponsor will notify the Pood and Drug Administration If the investigation is...

...effects attributable to the drug In each individual treated, and comparable records on any individúale employed as controls. These records shall be individual...investigation. 11. A statement that the sponsor will notify the Food and Drug Administration If the Investigation is discontinued, and the reason therefor. 12. A statement...

...individuals employed as controls. These records shall be individual records maintained for each subject to Include adequate information pertaining to each,...investigation. 11. A statement that the sponsor will notify the Food and Drug Administration if the investigation is discontinued, and the reason therefor. 12. A statement...

...for each subject to include adequate information pertaining to each, including age, sex, condittons treated, dosage, frequency of administration of the...investigation. 11. A statement that the sponsor will notify the Food and Drug Administration if the investigation is discontinued, and the reason therefor. 12. A statement...

...and a full statement of any adverse effects and useful results observed, together with an opinion aa to whether such effects or results are attributable...Investigation Is discontinued, and the reason therefor. 12. A statement that the sponsor will notify each Investigator If a new-drug application Is approved,...

...administration of the drag, results of all clinical observations and laboratory examinations made, full information concerning any other treatment given and...to the drug under investigation. "11. A statement as to whether or not the drug will be sold : and if so, a full explanation why sale is required and...

...administration of the drug, results of all clinical observations and laboratory examinations made, full information concerning any other treatment given and...to the drug under investigation. "11. A statement as to whether or not the drug will be sold ; aud if so, a full explanation why sale is required and...