CDER Updates Policy, Procedures for Responses to ANDA Inquiries

CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff.

Under the updated Manual of Policies and Procedures, released Aug. 18, OGD regulatory project managers will take the lead role in communicating with generics makers, starting with the filing of an application, to inform them of the target action date and when necessary product reviews may be completed.

Project managers in the Division of Filing Review will serve as contact points for questions about how to file information requests, while discipline project managers will issue IRs and easily correctible deficiencies. The discipline project manager will notify the OGD regulatory project manager before issuing an IR or ECD to confirm that the communication is appropriate.

Meanwhile, regulatory business process managers in OPQ will issue all quality-related IRs and ECDs, coordinating with OGD staff if the target action date is nearing.

The new responsibilities come in response to industry complaints of limited communications on ANDA inquiries and are meant to ensure more frequent responses.

The new MAPP replaces a September 2013 version. View it at — Jonathon Shacat


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