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# Steps to Ease Generic Drug Review
- URL: https://www.fdaweb.com/steps-to-ease-generic-drug-review/
- Published: 2018-01-03T12:00:00.000Z
- Updated: 2026-09-14T23:10:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140402

FDA commissioner **Scott Gottlieb** says the agency has issued a draft guidance and a Manual of Policies and Procedures (MAPP) intended to help improve the efficiency and predictability of the agency’s generic drug review process to reduce the time it takes to get a new generic drug approved and lessen the number of review cycles undergone by generic applications before they can be approved. In a [statement](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm591184.htm?ref=fdaweb.com), Gottlieb says the [guidance](http://www.fda.gov/downLOADS/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM591134.pdf?ref=fdaweb.com), *Good ANDA Submission Practices*, highlights common, recurring deficiencies seen in generic drug applications that may lead to a delay in their approval.

“One key reason why generic approvals are delayed is that many applications need to undergo multiple cycles of review,” Gottlieb writes. “While often this is because the application lacks sufficient scientific evidence to support approval, there are also many times when FDA must ask applicants for additional information in order to determine that the requirements for approval have been met, even if an application meets the threshold for filing. In fact, it currently takes on average about four cycles for an ANDA to reach approval, and not necessarily because the product will not meet our standards, but sometimes because the application is missing information necessary to demonstrate that it does.”

The guidance says that common deficiencies are identified during FDA’s substantive assessment of an ANDA with respect to patents and exclusivities, labeling, product quality, and bioequivalence. The guidance gives ANDA sponsors recommendations on how to avoid the deficiencies, with the goal of minimizing the number of review cycles necessary for approval.

Gottlieb says the MAPP, *Good ANDA Assessment Practices*, outlines agency assessment practices for staff and formalizes a more streamlined generic review process, including introducing new templates to make each review cycle more efficient and complete. The document: 

- establishes that assessment teams should, when available, use templates and assessment tools provided by the sub-disciplines that focus the primary assessment of quality, bioequivalence, or labeling data or information on the critical attributes of the application;
- clarifies the roles and responsibilities of primary assessors, secondary assessors, and division directors to reduce duplicative and unnecessary work; and
- · establishes that the Office of Generic Drugs (OGD) Office of Pharmaceutical Quality (OPQ) will clearly communicate to applicants what deficiencies must be corrected for their ANDAs to be approved.

“Collectively,” the MAPP says, “these changes are expected to expand access to generic medicines and enable OGD’s and OPQ’s highly trained experts to focus more of their attention on novel or challenging scientific and policy issues associated with the development and assessment of generic drug products.”

Gottlieb says the goal is to ensure that generic drug makers are made fully aware of the problems that are delaying the approval of their applications and understand how to fix them. He says that both the guidance and the MAPP should reduce the number of subsequent cycles that applications must undergo, and avoid the cycling of applications that is a significant cause of the delays in generic approvals.