{"data":{"id":"us/21-cfr-600.90","jurisdiction":"us","citation":"21 CFR 600.90","heading":"Waivers.","body":"(a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 600.80 and 600.81. A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain one of the following:\n(1) An explanation why the applicant's compliance with the requirement is unnecessary or cannot be achieved,\n(2) A description of an alternative submission that satisfies the purpose of the requirement, or\n(3) Other information justifying a waiver.\n(b) FDA may grant a waiver if it finds one of the following:\n(1) The applicant's compliance with the requirement is unnecessary or cannot be achieved,\n(2) The applicant's alternative submission satisfies the requirement, or\n(3) The applicant's submission otherwise justifies a waiver.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER F—BIOLOGICS","PART 600—BIOLOGICAL PRODUCTS: GENERAL","Subpart D—Reporting of Adverse Experiences"],"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":"5f70251c49342580298842ca48807359813f0cc5318624e10a60fb922fc36fab","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-600.82","next":"us/21-cfr-601.2"},"notice":"GroundRules: Original legal text. Not legal advice."}