Dr Sally Choe, Director, Office of Generic Drugs, outlined the actions that OGD has taken for outreach to stakeholders, citing the many workshops and seminars in which OGD participated.  She provided a view of the GDUFA regulatory science initiatives, including guidance on complex products, internal alignment on complex issues, confidence in generic substitution, review tool development, and faster and smarter generic drug development and review.

To assist generic drug development, she noted OGD’s pre-submission process, which includes the controlled correspondence program and the pre-ANDA meetings for complex products.  In addition, the availability of product-specific bioequivalence guidance (PSG) provides firms a road map for establishing bioequivalence evaluation of products which will lead to therapeutic equivalence determinations upon approval.

Clear communication between FDA and industry is paramount to achieve success in the application review and approval process. In addition, complete and timely response by industry in response to information requests, discipline review letters, or complete response letters will drive the timeline for review and approval. In addition, she issued a plea for firms to withdraw any pending application that they are no longer interested in seeking approval which can reduce the burden on the agency review process.

Noting the record breaking year for OGD approvals (see previous post here), Dr. Choe sees that industry and the FDA improving the use of best practices will lead to continued success for OGD and applicants!