Last week, the U.S. Food and Drug Administration (FDA) issued two significant draft guidance documents concerning the use of artificial intelligence (AI) in medical devices and in drug and biological ...

Figure 1. Average review times for traditional and abbreviated 510(k) applications in FY 2002 for Class II devices.(click image to enlarge) FDA plans to create guidance documents as technologies are ...

On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the ...

Add Yahoo as a preferred source to see more of our stories on Google. Dr. Vinay Prasad, director of the FDA's Center for Biologics Evaluation and Research, said he disagreed with reviewers’ ...

The US Food and Drug Administration (FDA) on Friday released draft guidance describing how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation ...

US regulators are coming under renewed scrutiny regarding their oversight of pharmaceutical compounders, with House legislators threatening to subpoena the US Food and Drug Administration for what ...

FIRST ON THE DAILY SIGNAL—Former Vice President Mike Pence’s think tank formally asked the Food and Drug Administration on Friday to turn over documents related to the dangers of the abortion pill, ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

America First Legal (AFL) sued the Food and Drug Administration on Friday to obtain Biden-era records related to the government's internal guidance for the recommended use of puberty blockers for kids ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show. Dr. Vinay Prasad, ...