eCFR Reference Browser

---

title: "21 CFR §601.93"

source: "https://www.ecfr.gov/current/title-21/section-601.93"

title_number: "21"

volume_number: "7"

chapter_number: "Unknown"

subchapter_code: "F"

subchapter_subject: "BIOLOGICS"

part_code: "601"

part_subject: "LICENSING"

subpart_code: "H"

subpart_subject: "Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible"

section_number: "601.93"

section_subject: "Postmarketing safety reporting."

cfr_reference: "21 CFR 601.93"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 600 to 799"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

Biological products approved under this subpart are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.

§601.93 - Postmarketing safety reporting.