The FDA has announced a new pilot program to speed up the review of generic drug applications produced entirely within the United States, as part of a broader push to strengthen domestic manufacturing and reduce dependence on foreign supply chains.
The pilot program offers priority review to Abbreviated New Drug Applications (ANDAs) for products that meet three criteria: bioequivalence testing conducted in the U.S., final dosage form manufacturing within the country, and active pharmaceutical ingredients (APIs) sourced exclusively from U.S.-based suppliers.
The initiative responds to significant overseas reliance in the generic drug sector, where over half of U.S. pharmaceuticals are produced abroad and only 9% of API manufacturing occurs domestically. By fast-tracking applications from domestic facilities, the FDA aims to improve national drug security, reduce inspection costs, and accelerate access to high-quality generics for American patients.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox!
Sign up now!