New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles va...
FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.
FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.
FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional research sites does...
FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agency is following the ...
FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facili...
The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone.
An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...
