Drugs

Comments on Advanced Mfg. Tech Guide

The API Innovation Center makes these recommendations on an FDA draft guidance on the advanced manufacturing technologies (AMT) designation program:

consider whether to limit AMT designations to the U.S. and whether to include an accelerated review component;
distinguish incentives between generic and branded manufacturers;
expand the definition of AMT with flexibility; and
enhanced guidance on prioritization and incentives.

The association says its drug-manufacturing member companies raised these questions:

whether FDA will consider if AMT should be used only in the U.S. rather than allowing outside the U.S. manufacturing to benefit from the designation;
whether FDA will target and encourage both generic and branded manufacturers;
what qualifies as an AMT and how much of the production process would have to implement AMT to receive the designation; and
whether FDA will provide a plan for prioritization, market changes and incentives, and additional examples in the final guidance.

In its comment letter, the Biotechnology Innovation Organization (BIO) says the guidance “is very high-level and would benefit to include further scope and descriptions of the program, along with clarity on its distinct benefits. In addition, this guidance needs further elaboration as to how this designation differs from existing programs and if they can be utilized separately or synergistically.” The letter lists seven topics that BIO believes would benefit from clarifications and line-by-line technical comments.

The United States Pharmacopeia (USP) says it commends FDA’s ongoing efforts related to AMT and engagement of stakeholders to identify and address impediments to AMT adoption and implementation. It offers to discuss with FDA how USP can support the agency in developing standards and policies needed to support designated technologies and the adoption and implementation of AMTs.

Finally, BIO provides specific line-by-line technical comments and suggestions.

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