FDA researchers say the alternative tools employed in CDER inspections during the pandemic were critical to informing agency regulatory decisions whil...
The CDER Office of Pharmaceutical Quality 2022 annual reports touts how alternative review techniques aided regulatory decision-making during the Covi...
CBER director Peter Marks tells a conference he would like to see a Project Orbis-style multi-national effort to spur the development of cell and gene...
The Los Angeles Times says FDA is learning how to use social media to combat those promoting disinformation and denying science.
The U.S. Department of Justice says over $2.2 billion was collected in settlements and judgments under the False Claims Act during fiscal year 2022.
A new journal article by CBER reviewers finds uncertainty about assessment of the safety profile as a top discussion item at 24 advisory committee mee...
FDA clears a Hyperfine 510(k) for its upgraded Swoop AI-powered software for use with the Swoop Portable MR Imaging System.
FDA accepts for review an Ocuphire Pharma NDA for Nyxol (phentolamine ophthalmic solution 0.75%) for treating pharmacologically-induced mydriasis.
