FDA releases new guidance outlining generics review goals

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FDA releases new guidance outlining generics review goals

Home/Guidelines | Posted 08/08/2014 0 Post your comment

In July 2014, the US Food and Drug Administration (FDA) issued two new draft guidance documents, which outline the agency’s goals for speeding up its handling of regulatory submissions from generics makers.

The commitment to speed up the time that FDA spends on reviewing applications from generics makers comes as part of the Generic Drug User Fee Amendments of 2012 (GDUFA), which was approved by the US Congress on 21 September 2012 [1].

The two draft guidance documents outline goals for FDA by 2017 to review and act on 90% of some prior approval supplements (PASs) within six months and for amendments to abbreviated new drug applications (ANDAs) be acted on within 10 months.

Prior approval supplements under GDUFA
Date: July 2014
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf

Amendments and easily correctable deficiencies under GDUFA
Date: July 2014
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404440.pdf

Amendments have been grouped into three tiers, depending on whether the amendment is solicited or not and whether it is considered a major or minor amendment. Performance goals for FDA for Tier 1 and Tier 2 amendments vary from 3 months to 12 months, depending on the type of amendment filed.

The new performance goals for FDA will be phased in over a three-year period.

The performance goals described in the two guidance documents apply only to ANDA amendments and PASs submitted on or after 1 October 2014.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Generic drug user fees come into effect [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 8]. Available from: www.gabionline.net/Policies-Legislation/Generic-drug-user-fees-come-into-effect

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Source: FDA