FDA Issues Important New Guidances: Pre-ANDA and Controlled Correspondence

In October of this year, FDA issued guidance that for the first time formalized the Pre-ANDA Meeting for developers of complex generics. Entitled “Formal Meetings Between FDA and ANDA Applicants of Complex Products,” “This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit or an applicant that has submitted an abbreviated new drug application (ANDA) for a complex product to FDA as defined in this guidance. Specifically, this guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA.”

More recently, in November, FDA announced the availability of a draft guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.” “This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency’s process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA’ controlled correspondence response and the Agency’s process for responding to those requests. This draft guidance revises the guidance for industry ‘Controlled Correspondence Related to Generic Drug Development’ issued in September 2015.”

Here’s the full story from FDA on the Pre-ANDA program, and here’s a link to the new Controlled Correspondence guidance.

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