The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...

The COVID-19 pandemic forced investigators conducting clinical trials to use decentralized elements, such as telehealth, to ...

The US Food and Drug Administration has released draft guidance on protocol deviations, but experts say it could go further.

FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...

On January 6, 2025, the FDA issued draft guidance on applying artificial intelligence to drug and biologics development, responding to a marked uptick in AI-based regulatory submissions. For the ...

The FDA says that food companies will have until Jan. 15, 2027 to stop using the dye. Drugmakers will have an extra year, until January 2028, to comply with the change. Red 3, also known as ...

This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the ...

Scroll down to see the full list of affected products: The FDA announced today it was banning the use of red 3 dye in foods in America, telling thousands of manufacturers to strip it from their ...

The appraisal committee has prepared final draft guidance (FDG) on durvalumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell ...

You should read both the consultation document and the accompanying evidence (see the committee papers) before making any comments. You must make your comments ...

For many NFL teams, Week 18 is a window into playoff season. But for others, it marks the unofficial start to draft season. The finalization of the top of the first-round order provides some shape ...