News

Politico1mon
FDA names first-ever AI chief
Among the losses have been key tech talent, including Sridhar Mantha, former director of strategic programs at the Center for Drug Evaluation and Research. He co-chaired the AI Council at CDER and ...
FierceBiotech1mon
Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma
Matthew Warren, director of the FDA’s Office of Scientific Integrity. Warren wrote that CDER is working to thoroughly review Vanda’s submission and asked the FDA commissioner to issue a ...
Roll Call2mon
Senate confirms Makary for FDA commissioner
The Senate late Tuesday voted 56-44 to confirm Martin Makary to lead the Food and Drug Administration. Makary, a former Johns Hopkins University surgeon and author, has been widely seen as a more ...
Food Safety News3mon
FDA remains mum on source of outbreak
The FDA has again refused to provide information about the deadly 2024 E. coli O157 outbreak traced to romaine lettuce. Although the Food and Drug Administration knew what grower and distributor ...
Newsday3mon
FDA staff return to crowded offices, broken equipment and missing chairs
WASHINGTON — Thousands of employees returned to the Food and Drug Administration's headquarters Monday to find overflowing parking lots, long security lines and makeshift office spaces without ...
The Daily Signal3mon
FDA’s ‘Drug Safety Priorities’ Working Group Politicized Under Biden Administration
Per the FDA: The DRMB is a cross-CDER governance board responsible for three key objectives: (1) facilitating and coordinating decisions around major product safety issues, (2) providing clear and ...
FiercePharma5mon
FDA's Patrizia Cavazzoni to retire as CDER chief in 2nd senior official's departure in span of weeks
The seven-year FDA veteran communicated the decision in an internal communication viewed by Fierce Pharma. Her last day will be Jan. 18. “Leaving CDER was an extremely difficult decision ...
PharmTech6mon
FDA Creates CDER Center for Real-World Evidence Innovation
FDA announced on Dec. 12, 2024 that the Center for Drug Evaluation and Research (CDER) has created a Center for Real-World Evidence Innovation (CCRI). The CCRI will coordinate, advance, and promote ...
STAT8mon
The biggest challenge facing the FDA’s new Rare Disease Innovation Hub
Pitts, a former FDA associate commissioner ... and Research (CBER), the Center for Drug Evaluation and Research (CDER), patient organizations, and product innovators with the goal of ultimately ...
Food Safety News1y
FDA’s reorganization is official
Consumer Reports and the National Association of Food and Drug Officials applaud the approval of the FDA’s reorganization plan, saying the move will help ensure the nation’s food supply is safe.
The National Law Review1y
FDA Establishes CDER Center for Clinical Trial Innovation (C3TI)
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 ...