[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR314.500] [Page 170] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents Subpart H--Accelerated Approval of New Drugs for Serious or Life- Threatening Illnesses Sec. 314.500 Scope. Source: 57 FR 58958, Dec. 11, 1992, unless otherwise noted. This subpart applies to certain new drug products that have been studied for their safety and effectiveness in treating serious or life- threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy). [57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999]