Federal Register notice: FDA makes available a draft guidance entitled E6(R3) Guideline for Good Clinical Practice.
Federal Register notice: FDA revokes an emergency use authorization issued to B. Braun Melsungen AG for propofol-lipuro 1% injectable emulsion.
CBER updates information for regulated entities on the return to normal operations with the end of the Covid-19 public health emergency.
Legend Biotech files a supplemental BLA seeking to expand the label for Carvykti (ciltacabtagene autoleucel) to include the treatment of adult patient...
FDA medical reviewers ask members of the Peripheral and Central Nervous System Drugs Advisory Committee to confirm the benefits and risks of Eisai/Bio...
FDA warns Houston, TX-based physician Mobeen Mazhar about violations in conducting three clinical trials.
Five Hogan Lovells attorneys explain how an FDA proposal to require Patient Medication Information would represent a significant change in drug labeli...
FDA approves Mercks Prevymis (letermovir) for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients.
