clinical trials: phase iii restrictions

drugs disseminated during phase iii clinical trials, but after a preclinical submission has been filed, are subject to the following restrictions:

(a) all inner labels and outer labels used in conjunction with the sale of the new drug to qualified investigators must carry the statements

(i) "investigational drug" or "drogue de recherche", and

(ii) "to be used by qualified investigators only" or "rserve uniquement l'usage de chercheurs comptents";

(b) the drug manufacturer must ascertain that every qualified investigator to whom the new drug is to be sold:

(i) has the facilities for the clinical testing to be conducted by the investigator, and

(ii) has received certain information including the clinical testing protocol; and

(c) every qualified investigator to whom the new drug is to be sold has agreed in writing with the manufacturer that the investigator will

(i) not use the new drug or permit it to be used other than for clinical testing,

(ii) not permit the new drug to be used by any person other than the investigator except under the investigator's direction,

(iii) report immediately to that manufacturer and, if so required by the director, report to the director all serious adverse reactions encountered during the clinical testing, and

(iv) account to the manufacturer for all quantities of the new drug received, where so requested by the manufacturer.