News

STAT10dOpinion
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 ...
Med Device Online3d
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 ...
Pharmaceutical Technology on MSN4d
FDA layoffs and priority review 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 ...
Fierce Biotech10d
'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 ...
Fierce Pharma5d
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 ...
Healio3d
Confirmatory study delay after FDA accelerated approval should be ‘cautionary sign’
Cancer drugs that received accelerated approval from the FDA gained regular approval significantly faster if their ...
Novavax says its COVID-19 shot is on track for full FDA approval after delay
At FDA, full vaccine approval is the gold standard. The agency was on track to sign off on Novavax’s license by its April 1 ...
BioSpace12d
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express ...
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 ...
JD Supra10d
FDA Drug Inspections Post–Workforce Reductions: Potential Implications and Practical Steps Forward
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. 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 ...