News

Med Device Online21h
FDA RIFs Might Delay Your Review — Here Are Tips For Mitigating
Mounting concerns that FDA reviewers could start missing PDUFA deadlines have put many on edge. The moment calls for ...
BioSpace11d
FDA After the Storm: Drug Review Delays and Increased Executive Oversight Expected
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with ...
Fierce Biotech1d
Vanda sues FDA over hearing delay as agency points to mass layoffs, other litigation with the biopharma
Vanda Pharmaceuticals is suing the FDA again, this time alleging the agency is unlawfully delaying a hearing to discuss the ...
Pharmaceutical Technology on MSN2d
FDA layoffs and priority review voucher programme’s lapse disrupt rare disease pipeline
The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug ...
STAT7dOpinion
Five priorities to remake the FDA in a time of deep uncertainty
Two former FDA leaders look at Commissioner Marty Makary’s early stumbles — and lay out a list of priorities to protect both ...
Fierce Pharma2d
FDA asks Novavax for post-marketing data pledge amid stalled COVID shot review
On a recent call with analysts at BMO Capital Markets, a “former director” at the FDA’s Center for Biologics Evaluation and ...
Fierce Biotech7d
'An unwinnable situation': FDA delays force one biopharma to shelve phase 3 plans, WSJ reports
After mass layoffs, the FDA has started missing certain deadlines, pushing one biopharma to delay a phase 3 trial and ...
US to phase out many synthetic food dyes, Kennedy and FDA head say
They cited concerns about a possible link between consumption of the dyes and health conditions like ADHD, obesity and ...
Becker's Hospital Review7d
FDA layoffs stall new drug development: 5 notes
In recent weeks, biotech companies have faced setbacks in moving forward with clinical trials due to operational delays at the FDA, according ... jeopardize potential product launches — issues ...
Indianapolis Business Journal13d
FDA upheaval worries local companies
The Trump administration’s recent announcement that it plans to eliminate about 3,500 FDA jobs is creating uncertainty among ...
US FDA limits industry employees from roles in its advisory committees
U.S. Food and Drug Administration Commissioner Martin Makary announced on Thursday a policy to limit employees of companies ...