FDA is working to make the Abbreviated New Drug Application (ANDA) submission and assessment process more efficient by providing guidance to industry and establishing internal practices to help reduce the number of review cycles for an ANDA to attain approval. The newly released draft guidance for industry, Good ANDA Submission Practices, and the Manual of Policies and Procedures (MAPP) 5241.3, Good Abbreviated New Drug Application Assessment Practices, apply insights gained through the first five years of the Generic Drug User Fee Amendments (GDUFA) program.
Until now, approximately half of all ANDAs with GDUFA review goals required at least three review cycles to reach approval or tentative approval. The agency and industry found applications often required multiple review cycles to reach approval-- an inefficient and resource-intensive process that could delay access to safe, affordable generic medicines. GDUFA II includes important program enhancements to improve the predictability and transparency of ANDA assessments by fostering the development of high-quality submissions and resubmissions. cycle.
Good ANDA Submission Practices Guidance for Industry
The Good ANDA Submission Practices Guidance draft guidance lists common, recurring deficiencies that may lead to a delay in the approval of an ANDA, such as issues with patents and exclusivities, labeling, product quality, and bioequivalence. It also provides recommendations to applicants on how to avoid these deficiencies. Some of the highlights of FDA’s recommendations to prevent deficiencies include:
Patent and Exclusivity Deficiencies – Applicants should:
- Submit to FDA timely written documentation of the sending and receipt of notice of a paragraph IV certification, that the patent owner(s) and/or exclusive patent licensee filed a legal action, or a statement that the patent owner(s) and/or exclusive patent licensee did not file a legal action of receipt of the notice of the paragraph IV certification.
- Monitor the Orange Book and address newly-listed patents, revised patents, and exclusivities in a timely manner, as an applicant must not submit a paragraph IV certification to the ANDA for a newly-listed patent “earlier than the first working day after the day the patent is published in [the Orange Book].”
- Submit the required notification of commercial marketing to FDA within the 30-day time frame.