By the end of this year the US Food and Drug Administration (FDA) plans to release two documents with details of changes designed to streamline the review process for abbreviated new drug applications (ANDAs). These steps are part of the action plan to remove barriers to generic drugs.
The first document entitled “Good ANDA Assessment Practices” is an internal manual of policies and procedures (MAPP), designed to eliminate unnecessary procedures and duplication in reviews to make them more efficient.
Under the manual the level of supervisory oversight for ANDA reviews will be based on the level of experience of the primary reviewer and the relative risk and complexity of the product. The aim of this oversight is to validate each review.
For applications that are not approved, reviewers will be required to send the sponsor a complete response letter detailing what the issues are and how they can be rectified.
The second document will be guidance for industry on “Good ANDA Submission Practices” that will describe common issues found in ANDA submissions and give sponsors advice on how to avoid those issues prior to ANDA submission.