FDA ANDA Submissions Guidance - Prior Approval Supplements under GDUFA

• By: Staff Editor
• Date: April 07, 2017
• Source: http://www.fda.gov

FDA ANDA Submissions Guidance – Prior Approval Supplements under GDUFA

US FDA has issued a guidance, in October 2016, to aid pharma companies preparing to submit prior approval supplements (PASs) and amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the FD&C Act. The guidance further explains how the GDUFA relates to PAS submissions. Specifically, the guidance focuses on the following key areas:

• GDUFA performance metric goals for PAS submissions
• Fee related RTR standards and PAS submissions under GDUFA
• Inspection for PAS submissions
• Amendments to PAS submissions
• Other PAS related matters including submission of supplements

Changes to an Approved Application

Section 506A of the FD&C Act and § 314.70 of FDA regulations delivers requirements for making and reporting changes to an approved application for drug products. The following are different reporting categories for changes to an approved application:

• Major Change is a one that has a significant potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product. Hence, it requires the submission of a PAS and approval by FDA before distribution of the changed drug product.
• Moderate Change has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product. Depending on the nature of the change, one of the following types of supplements should be submitted to FDA:
• Supplement – Changes being effected in 30 days (CBE-30 supplement)
• Supplement – Changes being effected (CBE-0 supplement) as soon as FDA receives the supplement
• Minor Change that has minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product and must be described by an applicant in its next annual report.

The guidance addresses the above key areas and much more to ensure clarity in adhering to the FDA GDUFA requirements.