This latest FDA program aims to provide speedier reviews for generic drugmakers who produce their products in the U.S.
Keeping up its string of pilots in recent months, the FDA on Friday unwrapped a new program designed to promote the R&D and manufacturing of generic drugs in the U.S.
In particular, the FDA’s new program aims to speed up its reviews of abbreviated new drug applications—regulatory filings specifically for generics—though the regulator did not specify by how much it expects to accelerate the process. It typically takes about 10 months for the FDA to issue a verdict on generics applications.
To qualify for this new program, companies must be conducting bioequivalence testing in the U.S., and they must “exclusively” source their active pharmaceutical ingredients (API) from within the country, according to the regulator’s release. Applicants must demonstrate in their filings that they hit these criteria, and that the finished dosage form is also made in the U.S.
“Overreliance on foreign drug manufacturing and testing creates risks both to national security and patient access,” George Tidmarsh, director of the FDA’s Center for Drug Evaluation and Research, said in a statement on Friday.
More than half of the pharmaceuticals in the U.S. are imported, the FDA noted. 2025 data show that only 9% of API manufacturers are located in the country, the agency continued, as opposed to 22% in China and 44% in India.
Friday’s program, Tidmarsh said in the statement, helps ensure a “strong and resilient domestic drug supply” for the U.S. while also providing patients with “affordable access to needed medications.”
The FDA in recent months has rolled out several new programs designed to streamline the drug development process and improve patient access to medicines. In July, for instance, the agency piloted the Commissioner’s National Priority Voucher program, which looks to shorten drug reviews for products that meet certain criteria to 1–2 months from the typical 10-12-month timeframe.
For its first year of implementation, the Commissioner’s Voucher will be awarded to no more than five drugmakers who align with certain national priorities, including lowering drug prices in accordance with President Donald Trump’s Most Favored Nation rule.
Meanwhile, the FDA last month also released draft guidelines to help cell and gene therapy companies, outlining ways in which they can streamline their development processes. The regulator’s proposed changes include allowing self-controls during clinical trials and the use of real-world data as part of the post-approval monitoring process.
