Former FDA enforcement official suggests new strategies for industry to prepare for agency inspections that rely on artificial intelligence tools.
FDA officials are seeking to bolster confidence in generic medicines, highlighting the agency's oversight of drug manufacturing, inspection programs a...
FDA launches a new effort to aggregate clinical trial data on kidney safety biomarkers, seeking pharmaceutical industry participation in a pilot progr...
FDA issues an early alert warning healthcare providers about a potentially high-risk defect affecting certain infant resuscitation systems manufacture...
PhRMA calls on FDA to provide clearer regulatory expectations for the use of digital health technologies in drug development, arguing that adoption ha...
FDA approves an expanded indication for Pfizer's hemophilia treatment Hympavzi (marstacimab-hncq), allowing its use in additional patient populations.
Stakeholders at FDA's public hearing on the Commissioners National Priority Voucher program urge the agency to temporarily suspend the initiative and ...
The House passes FDAs appropriations bill for fiscal year 2027 that provides $7.1 billion for the agency.
