A new effort called Operation Stork Speed aims to fix outdated FDA rules that block alternative baby formulas from reaching U ...

The US Food and Drug Administration’s new standards for foods before they can be labeled as “healthy” on their packaging will go into effect about two months later than planned, according to ...

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving ...

Business New FDA rules for TV drug ads: Simpler language and no distractions The new rules, which cover both TV and radio, instruct drugmakers to use simple, consumer-friendly language when ...

Oncologists were one of the few provider groups to register support for the FDA rule, reflecting the challenge of assessing ...

I n May 2024, the US Food and Drug Administration (FDA) issued its ‘Final Rule’, asserting that laboratory-developed tests (LDTs) - otherwise known as in vitro diagnostics (IVDs) - were ...

FDA approved label changes for Breyanzi and Abecma, easing access by reducing monitoring rules and eliminating REMS safety program requirements.

The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking ...