FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
On January 7, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance, titled “Artificial ...
The NGO Doctors for America argued that HHS, CDC and FDA violated federal law in removing medical information from ...
Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...
The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...
On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...
A federal judge today, February 11, gave the Trump administration until 11:59 pm tonight to restore public documents and datasets that were abruptly removed or altered from federal health websites to ...
U.S. District Judge John D. Bates granted a restraining order temporarily reversing the Trump administration’s moves to ...
While the continued erosion of Biogen’s multiple sclerosis franchise and weaker-than-expected 2025 guidance doesn’t seem to ...