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# Priority ANDA Guidance Seeks Excessive Info: Teva
- URL: https://www.fdaweb.com/priority-anda-guidance-seeks-excessive-info-teva/
- Published: 2017-08-01T12:00:00.000Z
- Updated: 2026-09-14T22:38:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139273

Teva says that an FDA draft guidance on pre-submission facility correspondence associated with priority ANDA submissions seeks information that goes above and beyond what was included in the commitment letter for reauthorization of the Generic Drug User Fee Act. “The pre-submission facility correspondence guidance exceeds the details included in the commitment letter by stating that a ‘thorough’ description of the manufacturing process should be included, whereas the commitment letter only calls for ‘a description of the manufacturing process,’” Teva writes in a comment [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-D-3101-0005&attachmentNumber=1&contentType=pdf&ref=fdaweb.com). The company says that as a result of the draft guidance, the correspondence in its current form will be a deterrent to ANDA filers, thereby eliminating the intent for a shorter review for those applications that would bring benefit to the U.S. healthcare system by speeding access and competition in the market. It asks FDA to revise the draft guidance to remove language and requirements that are above and beyond what was negotiated and agreed with industry and included in the commitment letter. The company includes other line-by-line comments.