FDA publishes draft guidance for industry: Controlled Correspondence Related to Generic Drug Development

FDA publishes draft guidance for industry: Controlled Correspondence Related to Generic Drug Development

On November 2, 2017, the FDA published the notice of availability for the draft guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.”

This guidance explains what inquiries FDA considers to be controlled correspondence, how generic drug manufacturers and related industry or their representatives can submit controlled correspondence to the FDA requesting information related to generic drug development, and the Agency’s process for responding to these requests.

When finalized, this guidance will replace the September 2015 guidance for industry “Controlled Correspondence Related to Generic Drug Development.” The September 2015 guidance was issued as part of FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA I). This revised guidance is being issued to incorporate program enhancements related to the review of controlled correspondence in GDUFA II.

Additionally, the FDA has recorded a webinar providing an overview of this guidance. The presentation and accompanying slides are available on FDA.gov.

To comment on the draft guidance, please visit the public docket, FDA-2017-23947.

Direct link to the guidance: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM583436.pdf

Federal Register notice: https://www.federalregister.gov/documents/2017/11/03/2017-23947/guidance-controlled-correspondence-related-to-generic-drug-development