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FDA calls for comment on generics user fees guidelines Posted 20/02/2015

The US Food and Drug Administration (FDA) announced in a Federal register publication of 6 February 2015 the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation.

The agency in particular wants the public to comment on the draft guidance documents for generics user fees and on generics exclusivity.

FDA is soliciting comments from the public, including industry, consumers, patient groups, caregivers, and healthcare professionals on the five draft guidance documents related to the implementation of the GDUFA, which include [1]:

ANDA submissions – content and format of abbreviated new drug applications
Date: June 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400630.pdf

ANDA submissions – refuse to receive for lack of proper justification of impurity limits
Date: September 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM414598.pdf

ANDA submissions – amendments and easily correctable deficiencies under GDUFA
Date: July 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404440.pdf

ANDA submissions – prior approval supplements under GDUFA
Date: July 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM404441.pdf

Controlled correspondence related to generic drug development
Date: August 2014
www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM411478.pdf

The agency is also asking whether there are implementation issues related to the five draft guidance that have not been addressed, what other GDUFA implementation topics need the development of guidance, and whether there are any topics or issues related to generic drug development other than those related to GDUFA implementation that need the development of guidance.

With respect to generics exclusivity FDA is asking for comments on:

  • whether FDA’s consideration of eligibility for 180-day exclusivity for a specific drug product be a public process
  • what legal or regulatory mechanisms, if any, are available to better facilitate FDA’s determination of and orderly resolution of sponsors' challenges to 180-day exclusivity determinations
  • whether there are other topics related to 180-day exclusivity which require comment
  • whether there are topics related to 180-day exclusivity that would benefit from FDA guidance.

What happens next?
Comments and suggestions regarding this notice can be submitted to www.regulations.gov or to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments and suggestions should be submitted by 9 March 2015.

Related article
FDA calls for comment on biosimilars interchangeability

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. US guidelines for generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Feb 20]. Available from: www.gabionline.net/Guidelines/US-guidelines-for-generics 

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Source: US Federal Register

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