Layoffs at the Food and Drug Administration are expected to reduce the FDA's workforce by 20%. Susan Mayne, former director of the Center for Food Safety and Applied Nutrition at the FDA ...

Minnesota is home to hundreds of medical device companies that can't sell new technologies or produce revenue without FDA review. A federal official did not answer questions about the cause of the ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as recent layoffs have reportedly had ...

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company's Pre-Market Approval (PMA) application for the Genio ...

In this first installment of "Exit Interviews," MedPage Today editor-in-chief Jeremy Faust, MD, sits down with two-time FDA Commissioner Robert Califf, MD, to discuss what it was like running a ...

As President Donald Trump’s massive overhaul of federal agencies continues, several former FDA officials spoke about the potential ramifications for drug reviews and provided a look inside curre ...

The delay dovetails with moves by Republican lawmakers in at least 7 states to ban or limit mRNA vaccines. HealthDay News — The US Food and Drug Administration (FDA) has delayed the full ...

The FDA has ordered Raptim Research, a clinical research company based in India, to redo several studies after the agency found evidence of data falsification. The FDA’s investigation ...

The FDA cleared the investigational new drug application for ALX2004, with phase 1 trials expected to begin in mid-2025 for EGFR+ solid tumors. The FDA has cleared the investigational new drug (IND) ...

The U.S. Food and Drug Administration (FDA) has notified an unspecified number of drug companies that data from all in vitro bioequivalence studies conducted by the Navi Mumbai-based contract ...

As reports surface detailing the extent of Robert F. Kennedy Jr.’s layoffs at the Department of Health and Human Services, FDA officials are sounding the alarm about their ability to review ...