CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to learn about inspection ...
Federal Register notice: FDA classifies endoscopic pancreatic debridement devices into Class 2 (special controls).
CBER posts an updated standard operating policy and procedure (SOPP) manual entitled SOPP 8404: Refusal to File (RTF) Procedures.
Federal Register notice: FDA classifies blood collection devices for cell-free nucleic acids into Class 2.
GSK says data from two clinical trials showed that depemokimab significantly reduces asthma exacerbations in patients with severe Type 2 inflammation.
FDA removes a partial clinical hold against Rezolutes RZ358 (ersodetug), an investigational drug for treating hypoglycemia caused by congenital hyperi...
FDA clears a Femasys 510(k) for its diagnostic device for checking the fallopian tubes to confirm permanent birth control placement.
The Association for Diagnostics and Laboratory Medicine raises significant concerns regarding the recent FDA final rule on laboratory-developed tests,...
