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# 2 ANDA Review Documents Coming: Consultants
- URL: https://www.fdaweb.com/2-anda-review-documents-coming-consultants/
- Published: 2017-08-17T12:00:00.000Z
- Updated: 2026-09-14T22:41:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139407

FDA hopes to issue by the end of the year a Good ANDA Assessment Manual of Practices and Procedures and a Good ANDA Review Practices document, according to information gathered by Lachman Consultants at a recent Waxman-Hatch meeting with commissioner **Scott Gottlieb**. In an online post, the consulting firm says the two documents “could go a long way towards standardizing the process and further putting forth FDA expectations regarding both the filing (receipt) of an ANDA and the review content of an ANDA.”

The post outlines concerns it says industry has had about FDA asking for items out of the blue, such as things that have not been asked of an applicant before or things that may be nice to know but are not necessarily essential to approval as outlined in existing guidance or past agency expectations. “These kinds of questions drive the industry nuts,” Lachman says, “especially when they have had other ANDAs approved without those questions being asked.”

The firm concludes that “there is still lots of work to be done on both FDA’s and industry’s side to resolve and improve the ANDA submission and review process. Let’s hope this is a step in the right direction. It would be interesting to know what FDA thinks of this issue in terms of how to improve the situation.”