FDA warns Katy, TX-based Wintech Medipro about multiple violations in its manufacturing and distribution of unapproved surgical masks.
Eleven Republican members of Congress ask FDA and other agencies to respond to disputed claims that FDA drug reviewers take it easy on companies for w...
FDA says staff from CDER and CBER are participating on a new International Council on Harmonization formal expert working group to develop a guideline...
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.
