21 CFR 312.50 - General responsibilities of sponsors.
|Actualizado a:||April 2013|
Title 21: Food and DrugsCHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER D: DRUGS FOR HUMAN USE PART 312: INVESTIGATIONAL NEW DRUG APPLICATION Subpart D: Responsibilities of Sponsors and Investigators 312.50 - General responsibilities of sponsors. Sponsors are responsible for selecting qualified investigators, providing them with the information they need to conduct an investigation properly, ensuring proper monitoring of the investigation(s), ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND, maintaining an effective IND with respect to the investigations, and ensuring that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug. Additional specific responsibilities of sponsors are described elsewhere in this part.