On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...

Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...

On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...

A federal judge today, February 11, gave the Trump administration until 11:59 pm tonight to restore public documents and ...

Scott Gottlieb supports a reversion to an earlier interpretation of the 21st Century Cures Act, which would exempt more types ...

The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...

The Trump administration had directed health agencies to place a notice condemning “gender ideology” on health webpages that ...

FDA considers the following action levels to be achievable by the food industry when control measures are taken to minimize the presence of lead.

While the continued erosion of Biogen’s multiple sclerosis franchise and weaker-than-expected 2025 guidance doesn’t seem to ...

The NGO Doctors for America argued that HHS, CDC and FDA violated federal law in removing medical information from ...