FDA sends an untitled letter to Pinnacle Biologics, citing promotional videos for cancer therapy Photofrin (porfimer sodium).
FDA says it will not accept medical device test data generated by CCIC Huatongwei International Inspection in China because the agency has found sever...
Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under former commissioner ...
The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.
Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chinese-manufactured networked medical devices deemed...
A newly published commentary in the journal Stem Cell Research & Therapy says FDAs efforts to reduce reliance on animal testing is driving a fundament...
Three stakeholders comment on an FDA request for information on AI-enabled optimization of early-stage clinical trials.
Two stakeholders ask for greater specificity in an FDA draft guidance on establishing impurity specifications for antibiotics.
