FDA releases new guidance to speed generic drug review

Jan. 4, 2018

The FDA has released two documents that together are designed to streamline and improve aspects of the submission and review of generic drug applications.

The first — "Good ANDA Submission Practices”— is a draft guidance that aims to help applicants avoid common deficiencies that lead to review delays and application cycling, with the goal of reducing the number of review cycles. The guidance highlights common, recurring deficiencies seen in generic drug applications that may lead to a delay in their approval.

The Agency is also publishing a companion to the guidance in the form of a Manual of Policies and Procedures (MAPP) – "Good ANDA Assessment Practices" – which outlines ANDA assessment practices for FDA staff. The document formalizes a more streamlined generic review process, including the introduction of new templates that will make each cycle of the review process more efficient and complete.

According to the Agency, the new policies and those that are anticipated in early 2018 represent the FDA’s “ongoing work on the Drug Competition Action Plan— one of the FDA’s highest priorities in 2018. In the coming year, we’ll [FDA] be taking additional steps to improve our own practices and to help guide industry to make sure their generic drug applications can be acted upon as efficiently as possible.”

Read the FDA press announcement