Today, the U.S. Food and Drug Administration announced it had granted Gardenia Blue Interest Group’s (GBIG) color additive petition to use the color gardenia (genipin)…

As I mark my hundredth day on the job at the FDA, I’m proud to celebrate the agency’s accomplishments in the bipartisan effort to Make…

The U.S. Food and Drug Administration (FDA) today published more than 200 decision letters, known as complete response letters (CRLs). The CRLs were issued in…

The U.S. Food and Drug Administration today called for increased attention to product recall communications from industry leaders involved in the manufacturing and distribution of…

The U.S. Food and Drug Administration announced today that it has eliminated the Risk Evaluation and Mitigation Strategies (REMS) for currently approved BCMA- and CD19-directed…

The U.S. Food and Drug Administration today announced its Commissioner’s National Priority Voucher (CNPV) program to enhance the health interests of Americans. The new voucher…

The U.S. Food and Drug Administration (FDA) today launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees—from scientific reviewers to investigators—work more…

The U.S. Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) issued General Correspondence Letters to two third-party testing companies in China…

The U.S. Food and Drug Administration (FDA) today announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, with an estimated…

The U.S. Food and Drug Administration is continuing to take steps to help state importation programs provide safe, effective and more affordable drugs for American…