Alston Bird attorneys say the drug industry must be prepared for FDA to creatively use existing authorities instead of physical inspections to ensure ...
Bristol Myers Squibb says it will not initiate any new clinical trials globally before 4/13 due to coronavirus concerns.
Federal Register notice: FDA cancels a 4/14 public meeting entitled International Cooperation on Cosmetics Regulation Preparation for ICCR-14 Meeting...
FDA says it will fund projects to help it better understand using real-world data to generate real-world evidence.
PhRMA says FDA should change a proposed survey on promotional implications of proprietary drug names if it intends to proceed with the survey.
FDA approves a Samsung Bioepis supplemental BLA for a 420 mg multi-dose vial of Ontruzant (trastuzumab-dttb), a biosimilar referencing Genentechs Herc...
Federal Register notice: FDA announces its process for making available guidance documents related to the coronavirus public health emergency.
FDA accepts for priority review a Jazz Pharmaceuticals NDA JZP-258 (oxybate), an investigational drug for treating cataplexy or excessive daytime slee...