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CFR - Code of Federal Regulations Title 21

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[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2009]
[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.

 
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