BioSpace1h
FDA Faces ‘Catastrophic Collapse’ as Massive Layoffs Endanger User Fee Program
The FDA derives just under half of its yearly funding from pharma user fees, which help support its operations and fund ...
The Harvard Crimson22h
FDA Layoffs, Funding Cuts Cast Shadow Over Biopharma Industry
Amid a raft of federal changes cutting funding and capacities at the Food and Drug Administration, investors are soon ...
FDA layoffs could raise drug costs and erode food safety
Trump cutbacks were supposedly aimed at administrators. But scientists in food and drug-testing labs and policy experts who ...
JD Supra16d
FDA Funding Changes Could Impact Biotech M&A
Cash Runway Concerns: Funding and workforce reductions will stretch the FDA’s already limited resources. While the FDA’s processes for reviewing new drug products rely significantly on user ...
Roll Call8d
Targeting FDA user fees would leave agency gutted, experts say
Health and Human Services Secretary Robert F. Kennedy Jr. and his allies rallied around removing industry influence from the Food and Drug Administration as part of their quest to Make America ...
TwinCities.com29d
FDA nominee sidesteps questions on abortion pill, agency layoffs and other issues
He repeatedly assured Republican and Democratic senators he would follow the “scientific process” at FDA. But he wouldn’t commit to specific actions on a host of hot-button issues ...
Agri-Pulse16d
States prepare for steep cuts in food safety inspection funds
At a recent confirmation hearing for FDA Commissioner-nominee Martin Makary, Sen. Lisa Murkowski, R-Alaska, raised concerns about funding cuts to state food safety programs. Both House and ...
FiercePharma7d
Manufacturing issues trip up Milestone's long-awaited FDA landmark
In a complete response letter (CRL), the FDA cited two chemistry, manufacturing and control (CMC) issues. Milestone will have to address a problem with nitrosamine impurities. An FDA inspection ...
Seeking Alpha27d
DexCom falls after warning letter from FDA related to quality concerns
DexCom said that on Tuesday it received a warning letter from the U.S. FDA following inspections at its facilities in San Diego, Calif., and Mesa, Ariz. related to concerns about manufacturing ...