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# Generic Drug Correspondence Guidance Inadequate: AAM
- URL: https://www.fdaweb.com/generic-drug-correspondence-guidance-inadequate-aam/
- Published: 2021-03-09T12:00:00.000Z
- Updated: 2026-09-14T16:50:01.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148836

The Association for Accessible Medicines (AAM) says a 12/17/20 FDA final guidance, *Controlled Correspondence Related to Generic Drug Development*, is informative but “does not adequately cover the process related to development of a generic drug-device combination product.” The association’s comment [letter](https://downloads.regulations.gov/FDA-2014-D-1167-0023/attachment%5F1.pdf?ref=fdaweb.com) says that, as an example, the guidance does not address how a sponsor can share the design of its device and the proposed device for a generic combination product for evaluation by FDA during the early stages of development.

AAM also says it continues to have concerns with the quality and consistency of FDA responses to submitted controlled correspondence. Specifically, it says, the lack of meaningfulness and accuracy of FDA responses often generate a subsequent submission of a control or, worse, an ANDA submission that is rejected due to inaccurate or misleading agency recommendations provided to an applicant in a controlled correspondence.

The association also expresses concern with the growing number of controlled correspondences that are being submitted for inactive ingredient queries and other issues that contribute to the need for industry to submit controls.