Title 21: Food and Drugs
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/ 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 / § 314.630 Postmarketing safety reporting.
§ 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.