 | 1981 - 1252 pages
...using the same procedures, this is acceptable in lieu of the above assurances and a statement to this effect should be provided with the signed FD1571....are attributable to the drug under investigation. « • • • « (12) * * • Form FD-1572 * • • » • 3. If the experimental project is to be... | |
 | 1969 - 668 pages
...Investigations will be submitted to the Food and Drug Administration. (The notice of claimed Investlgatlonal exemption may be limited to any one or more phases,...that the sponsor will notify each investigator If a new-drug application Is approved, or if the Investigation is discontinued. 13. If the drug Is to be... | |
 | 1965 - 1520 pages
...may be limited to any one or more phases, provided the outline of the additional phase or phases la submitted before such additional phases begin. This...that the sponsor will notify each investigator If a new-drug application is approved, or If the Investigation is discontinued. 13. If the drug 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...that the sponsor will notify each Investigator if a new-drug appll§130.3 cation Is approved, or If the Investigation Is discontinued. 13. If tlir drug... | |
 | 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... | |
 | 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. Committee on Government Operations - 1964 - 844 pages
...submitted before such additional phases begin. This does not preclude continuing a subject on the dnig from phase 2 to phase 3 without interruption while...are attributable to the drug under investigation. II. A statement that the sponsor will notify the Food and Drug Administration if the Investigation... | |
 | 1968 - 656 pages
...results of all relevant clinical observations and laboratory examinations made, adequate lnformation concerning any other treatment given and a full statement...12. A statement that the sponsor will notify each lnvestigator if a new-drug application is approved, or if the investigation is discontinued. 13. If... | |
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Ordinarily, a plan for clinical trial will not be regarded as reasonable unless, among other things, it provides for more than one independent competent investigator to maintain adequate case histories of an adequate number of subjects designed to record... 
