The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics,…

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…

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…

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…

The U.S. Food and Drug Administration has issued a Request for Information (RFI) seeking input from venture capital firms on developing a new contracting approach…

The U.S. Food and Drug Administration today reminded industry of its legal responsibilities under the Federal Food, Drug, and Cosmetic Act regarding food recalls and…

The U.S. Food and Drug Administration (FDA) today removed a key limitation on the use of real-world evidence (RWE) used in drug and device applications…

The U.S. Food and Drug Administration today awarded a national priority voucher to teclistamab in combination with daratumumab for relapsed/refractory multiple myeloma. This brings the…

The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea. The FDA today approved…

Today, the U.S. Food and Drug Administration announced that it is taking action to advance sunscreen innovation, part of a broader initiative in the Office…