{"data":{"id":"us/21-cfr-314.98","jurisdiction":"us","citation":"21 CFR 314.98","heading":"Postmarketing reports.","body":"(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.\n(b) Each applicant must make the reports required under § 314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.","path":["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 C—Abbreviated Applications"],"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":"49f50452d302a9b28c723ee1cd2c454bbc79f7b5a46425fea619e178b9be8ad5","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-314.97","next":"us/21-cfr-314.99"},"notice":"GroundRules: Original legal text. Not legal advice."}