Title 21

PART 601 SUBPART E

Subpart E - Accelerated Approval of Biological Products for Serious or Life-Threatening Illnesses Source:57 FR 58959, Dec. 11, 1992, unless otherwise noted.

21:7.0.1.1.2.5.1.1SECTION 601.40
   601.40 Scope.
21:7.0.1.1.2.5.1.2SECTION 601.41
   601.41 Approval based on a surrogate endpoint or on an effect on a clinical endpoint other than survival or irreversible morbidity.
21:7.0.1.1.2.5.1.3SECTION 601.42
   601.42 Approval with restrictions to assure safe use.
21:7.0.1.1.2.5.1.4SECTION 601.43
   601.43 Withdrawal procedures.
21:7.0.1.1.2.5.1.5SECTION 601.44
   601.44 Postmarketing safety reporting.
21:7.0.1.1.2.5.1.6SECTION 601.45
   601.45 Promotional materials.
21:7.0.1.1.2.5.1.7SECTION 601.46
   601.46 Termination of requirements.