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FDA issues post-CRL meeting guidance for generics makers Posted 07/12/2018

In December 2018, the US Food and Drug Administration (FDA) published a new guidance document to assist generics makers with meetings with the agency following the issuance of a complete response letter (CRL).

The agency sends a CRL to an abbreviated new drug application (ANDA) sponsor if the agency determines that it will not approve the application in its present form due to one or more deficiencies.

This new guidance provides recommendations to generics makers on post-CRL meetings between FDA and ANDA applicants for the purpose of clarifying deficiencies identified in a CRL. Such post-CRL meetings are normally requested in writing by an ANDA applicant following receipt of a CRL.

Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
Date: December 2018

The agency wants to ensure that there are efficient, consistent procedures for the timely and effective conduct of post-CRL meetings. It believes that this guidance will assist applicants in generating and submitting a request for a post-CRL meeting and the associated meeting package to FDA.

In accordance with the Generic Drug User Fee Amendments (GDUFA) II Commitment Letter [1], FDA has committed to providing a scheduled date for 90% of post-CRL meetings within 10 calendar days of receipt of a written request. The agency has further committed to conducting 90% of post-CRL meetings held on an FDA-proposed date within 30 days of receipt of a written request.

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1.  GaBI Online - Generics and Biosimilars Initiative. FDA and industry agree on terms of GDUFA II reauthorization [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Dec 7]. Available from: www.gabionline.net/Policies-Legislation/FDA-and-industry-agree-on-terms-of-GDUFA-II-reauthorization

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Source: US FDA

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