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Single Telephone Contact for ANDA Queries Is Infeasible, FDA Officials Say

November 1, 2016

Generics makers want to be able to call a single designated official at the FDA to discuss their ANDAs, but the FDA doesn’t agree.

A single email account that directs the industry inquiries to the right experts and enables the agency to track responses is more appropriate for the Office of Generic Drugs, said Edward Sherwood, director of the OGD’s Office of Regulatory Operations.

Using email, rather than a telephone contact, ensures that responses are formal and consistent, Sherwood said. Plus, it ensures that industry receives high-quality responses in a timely manner.

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