{"data":{"id":"us/21-cfr-312.83","jurisdiction":"us","citation":"21 CFR 312.83","heading":"Treatment protocols.","body":"If the preliminary analysis of phase 2 test results appears promising, FDA may ask the sponsor to submit a treatment protocol to be reviewed under the procedures and criteria listed in §§ 312.305 and 312.320. Such a treatment protocol, if requested and granted, would normally remain in effect while the complete data necessary for a marketing application are being assembled by the sponsor and reviewed by FDA (unless grounds exist for clinical hold of ongoing protocols, as provided in § 312.42(b)(3)(ii)).","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 312—INVESTIGATIONAL NEW DRUG APPLICATION","Subpart E—Drugs Intended to Treat Life-threatening and Severely-debilitating 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":"339fca57f5d6de1b9c15fe7ee0299c0cc1b693e6fc9b25eff66845dc4a6b5042","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-312.82","next":"us/21-cfr-312.84"},"notice":"GroundRules: Original legal text. Not legal advice."}