FDA issues final guidance on generics information requests

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FDA issues final guidance on generics information requests

Home/Guidelines | Posted 11/12/2015 0 Post your comment

The US Food and Drug Administration (FDA) issued final guidance for generics makers on how to make formal requests for information. The final guideline, issued on 29 September 2015, provides information regarding the process by which generics makers can submit correspondence to FDA requesting information on generics development.

The guidance provides additional details and recommendations for the generics industry on:

what inquiries the FDA considers to be controlled correspondence for the purposes of meeting its GDUFA commitment
what information requestors can include in a controlled correspondence
what information FDA will provide in its communications to requestors that have submitted controlled correspondence

Controlled correspondence related to generic drug development
Date: September 2015
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM411478.pdf

FDA defines ‘controlled correspondence’ as ‘correspondence submitted to the agency, by or on behalf of a generic drug manufacturer or related industry, requesting information on a specific element of generic drug development.’ The agency adds that ‘controlled correspondence does not include citizen petitions, petitions for reconsideration, or requests for stay.’

The agency has also agreed to set certain goals for the timelines within which it will respond to requests. These include that:

FDA will respond to 70% of controlled correspondence within 4 months from the date of submission in fiscal year (FY) 2015
FDA will respond to 70% of controlled correspondence within 2 months from the date of submission in FY 2016
FDA will respond to 90% of controlled correspondence within 2 months from the date of submission in FY 2017
If the controlled correspondence requires input from the clinical division, one additional month will be added to the goals outlined above

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Source: US FDA