{"data":{"id":"us/21-cfr-601.44","jurisdiction":"us","citation":"21 CFR 601.44","heading":"Postmarketing safety reporting.","body":"Biological products approved under this program are subject to the postmarketing recordkeeping and safety reporting applicable to all approved biological products.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 601—LICENSING","Subpart E—Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"82dd7efd360c03ac5b020e12b11b76819b978dfa2a6f7f200560ce07cbec33fe","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-601.43","next":"us/21-cfr-601.45"},"notice":"GroundRules: Original legal text. Not legal advice."}