CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER D—DRUGS FOR HUMAN USE (parts 300 to 370) > PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG > SUBPART H—Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses (§314.500 to §314.560) > 314.500—Scope.

314.500—Scope.

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).

Code of Federal Regulations

[57 FR 58958, Dec. 11, 1992, as amended at 64 FR 402, Jan. 5, 1999]