21 CFR 312.50 - General responsibilities of sponsors.

Code of Federal Regulations - Title 21: Food and Drugs (2010)

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Title 21: Food and Drugs

CHAPTER 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 responsibile 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.


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