"The FDA's rigorous, science-based global inspections of manufacturing facilities ... undermining the integrity of the oversight process," the FDA continued. It said despite foreign entity's ...

Alexander Tin is a digital reporter for CBS News based in ... Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted ...

Nearly 1 in 5 positions across the Food and Drug Administration's human food inspection divisions are now vacant, multiple ...

Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...

On Tuesday, the U.S. Food and Drug Administration announced a new initiative to offer expedited reviews for new medicines, an ...

The U.S. FDA announced this week that it deployed a generative AI tool called ELSA, now in use by staff across the agency, ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

There are problems with generative AI, and there need to be guardrails and there needs to be human oversight," said Jason ...

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical ...

Investing.com -- Capricor Therapeutics Inc (NASDAQ: CAPR) stock tumbled 10.5% after the company announced that the FDA’s inspection of its San Diego manufacturing facility resulted in a Form 483 with ...