CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 5]

[CITE: 21CFR314.630]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER D - DRUGS FOR HUMAN USE

PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

Subpart I - Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible

Sec. 314.630 Postmarketing safety reporting.

Drug products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting requirements applicable to all approved drug products, as provided in §§ 314.80 and 314.81.