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U.S. Department of Health and Human Services

Drugs

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Postmarketing Safety Reporting Requirements for Drug and Biologic Products

This website serves as a resource to applicants, licensed manufacturers, packers, distributors and responsible persons subject to FDA’s requirements for postmarketing safety reporting for human drugs and biological products under 21 CFR §§ 310.305, 314.80, 314.98, 600.80, 1271.350 and Section 760 of the Food Drug and Cosmetic Act (FDCA). 

Regulations and Laws:

 Regulation or Law  Product
 21 CFR § 310.305

Prescription drugs marketed for human use without approved new
drug applications

 21 CFR § 314.80 Drugs with approved new drug applications (NDAs)
 21 CFR § 314.98 Drugs with approved abbreviated new drug applications (ANDAs)
 21 CFR § 600.80

Biologics with approved biologics license applications (BLAs)

 21 CFR § 1271.350 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
 Section 760 of the FDCA

Nonprescription human drug products marketed without an
approved application

             

Guidances:

Proposed Rules:

Other Resources: