FDA’s Prioritization Pilot Providing Faster Review When Generic Drugs — APIs or Finished Products — Are Produced Domestically

At a Glance

• This pilot offers priority review to generic drug applications — a benefit traditionally reserved for reference products that address serious clinical needs.
• The pilot is not automatically applied to all ANDA submissions; applicants need to identify their eligibility and request prioritization based on their U.S.-based manufacturing of the finished dosage form and/or API.

On October 7, 2025, the U.S. Food & Drug Administration (FDA) announced a new prioritization pilot program to accelerate the review of Abbreviated New Drug Applications (ANDAs) for generic drugs manufactured in the United States, including those using domestically produced active pharmaceutical ingredients (APIs). This pilot offers priority review to generic drug applicants — a benefit traditionally reserved for new or reference products that address serious clinical needs. By basing the eligibility on location of manufacturing operation, FDA is taking this unprecedented regulatory step to strengthen the domestic pharmaceutical supply chain, simultaneously reducing reliance on foreign sources and increasing the number of well-paying U.S. jobs.

How the Pilot Works

Under this pilot program, ANDA applicants may qualify for priority review if their generic drug products are manufactured domestically. FDA is considering not just where the finished dosage form is produced, but also where the API is sourced, giving preference to ANDA submissions for finished generic drugs that use APIs manufactured in the United States. By expediting the review of generics with U.S.-based manufacturing components, FDA aims to reduce reliance on foreign suppliers and strengthen the nation’s drug supply chain.

Typically, priority review by FDA is reserved for new drug applications or reference products that address serious clinical needs, offer significant improvements in safety or effectiveness, or respond to public health emergencies. ANDAs rarely qualify for priority review under these traditional criteria.

With this pilot program, FDA is now offering priority review for generic drug applications based on the domestic location of manufacturing for the finished drug or its API. This is a departure from past practice and is intended to enhance the security and resilience of the U.S. pharmaceutical supply chain.

The pilot is not automatically applied to all ANDA submissions; applicants need to identify their eligibility and request prioritization based on their U.S.-based manufacturing of the finished dosage form and/or API. FDA’s announcement states that eligible applicants should follow the instructions provided for seeking pilot consideration as part of their ANDA submission process.

Recommendations

If you manufacture generic drug products or source APIs domestically, you likely meet the eligibility criteria for participation in the new pilot. Consider whether adjusting your supply chains would allow you to take advantage of regulatory prioritization — faster FDA review and approval — through participation in this pilot program.

For More Information

For more details, see FDA’s announcement. For further information, you may contact the author or the firm’s FDA-regulated products team.