The U.S. Food and Drug Administration today announced its initial review of the effectiveness of the FDA ImportShield Program (FISP), which launched in August 2025 to modernize how the FDA reviews imp...

Today, the U.S. Food and Drug Administration issued a Request for Information (RFI) regarding labeling and preventing cross-contact of gluten in packaged food. The FDA is taking this action as a first...

The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make be...

The U.S. Food and Drug Administration today announced it is sharing information about the agency’s flexible approach to overseeing chemistry, manufacturing and control (CMC) requirements for cell and...

The U.S. Food and Drug Administration today released a congressionally mandated report under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) evaluating the use of perfluoroalkyl and poly...

The U.S. Food and Drug Administration today awarded national priority vouchers under the Commissioner’s National Priority Voucher (CNPV) pilot program to two investigational products for their potenti...