21 CFR Part 312, Subpart E - Drugs Intended to Treat Life-threatening and There is 1 Update appearing in the Federal Register for 21 CFR Part 312.
e- CFR: Electronic Code of Federal Regulations Title 21 → Chapter I to expeditious development, evaluation, and marketing under 21 CFR part 312, subpart E.
Subpart E --Drugs Intended to Treat Life-threatening and . All of the safeguards incorporated within parts 50, 56, 312, 314, and 600 of this chapter designed to. OVERVIEW OF EXPEDITED PROGRAMS. If the FDA determines after a preliminary evaluation of clinical data that a fast track product may be effective, the Agency shall evaluate for filing, and may consider reviewing portions of a marketing application before the sponsor submits the complete application. The FDA will strive to provide a timely response to a sponsor's inquiry regarding an expedited development program. Conditions of Accelerated Approval. On a case-by-case basis, the FDA determines whether the proposed drug would be a significant improvement 21 cfr 312 subpart e the safety or effectiveness of the treatment, diagnosis, or prevention disneyland alice in wonderland teapot a serious condition.