The agency is proposing a requirement that companies submit data when self-affirming an additive is safe for consumption.

Dr. Erik Langhoff, chief medical officer and consultant for the Bronx Regional Health Information Organization, discusses how ...

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...

The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare ...

The FDA said it would start releasing rejection letters soon after they are provided to drugmakers, a victory for ...

With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month ...

FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug ...

Philip Morris wins court fight to block new cigarette warning labels and ads Judge says FDA failed to disclose raw study data ...