 | 1965 - 1520 pages
...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... | |
 | 1979 - 1056 pages
...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... | |
 | 1981 - 1252 pages
...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... | |
 | 1964 - 1242 pages
...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... | |
 | 1971 - 676 pages
...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... | |
 | 1986 - 1610 pages
...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... | |
 | 1978 - 860 pages
...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... | |
 | 1977 - 1080 pages
...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,... | |
 | United States. Congress. House. Committee on Interstate and Foreign Commerce - 1962 - 734 pages
...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... | |
 | United States. Congress. House. Interstate and Foreign Commerce - 1962 - 732 pages
...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... | |
| |
... of any and all discernible effects attributable to the drug in each individual treated, and comparable records on any individuals employed as controls. These records shall be individual records for each subject maintained to include adequate information... 
