federal_register: 2014-12534

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2014-12534 Guidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Expedited Programs for Serious Conditions--Drugs and Biologics." The purpose of this guidance is to provide a single resource for information on FDA's policies and procedures related to expedited drug development and review programs. The following programs are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition (expedited programs): Fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation. This guidance finalizes the draft guidance issued in June 2013. 2014-05-30 2014 5 https://www.federalregister.gov/documents/2014/05/30/2014-12534/guidance-for-industry-on-expedited-programs-for-serious-conditions-drugs-and-biologics-availability https://www.govinfo.gov/content/pkg/FR-2014-05-30/pdf/2014-12534.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Expedited Programs for Serious Conditions--Drugs and Biologics." The purpose of this guidance is to provide a single resource for information on...

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