Three stakeholders suggest changes to an FDA revised draft guidance on nonclinical safety evaluation of drugs and biologics immunotoxicity potential....
Three stakeholders give general and specific comments on an FDA draft bridging guidance for combination products.
Former FDA commissioner Donald Kennedy (1977-1979) dies due to Covid-19 at the age of 88.
Biogen says it is delaying a BLA for aducanumab, a potential treatment for Alzheimers disease that it is developing in collaboration with Eisai Co.
FDA commissioner Stephen Hahn provides a teleconference briefing to House Energy and Commerce Committee members on the agencys response to the coronav...
FDA struggles with policy fallout after allowing dozens of Covid-10 serology (antibody) tests to come onto the market without its normal vetting or re...
Federal Register notice: FDA makes available a draft guidance entitled Technical Considerations for Demonstrating Reliability of Emergency-Use Injecto...
Braun Medical recalls one lot of ceftazidime for injection (2g) and dextrose for injection (50 ml) in its duplex container due to stability issues.