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 several instances in which the company copied results from another study or falsified data.
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 several instances in which the company copied results from another study or falsified data.
Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under former commissioner Marty Makary and praised current efforts to restore a normal policymaking process.
The FY2025 FDA Report on the State of Pharmaceutical Quality shows increased quality assurance inspections over FY 2024.
