Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Expedited Program for Serious Conditions--Accelerated Approval of Drugs and Biologics." Accelerated approval is one of FDA's expedited programs intended to facilitate and expedite development and review of certain drugs and biological products for serious or life-threatening conditions. This guidance provides information on FDA's policies and procedures for the accelerated approval program, including discussions of which products may be candidates for accelerated approval, the standards for granting accelerated approval, and the procedures for withdrawing accelerated approval. When finalized, this draft guidance will replace the accelerated approval-related content in the final guidance for industry entitled "Expedited Programs for Serious Conditions--Drugs and Biologics" issued on May 30, 2014 (the 2014 final guidance). Additional programs to expedite product development are covered in the 2014 final guidance as well as other guidances.
Abstract as published in the Federal Register.
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