Biologics
CBER HCT/P Inspection Data Published
CBER says the number of HCT/P inspections was down in FY 2019.
Human Drugs
FDA Approves Dupixent for Pediatric Atopic Dermatitis
FDA approves a Sanofi BLA for Dupixent (dupilumab) for children aged six to 11 years with moderate-to-severe atopic dermatitis whose disease is not ad...
Biologics
Cell2in Asks FDA OK for Glutathione Monitoring for BLAs
Cell2in asks FDA to update guidances to identify real-time glutathione monitoring as an acceptable measure of potency for use in submitting a BLA for ...
Medical Devices
PMA, HDE Supplement Covid-19 Guidance
FDA says it will not object to some design or manufacturing modifications for devices approved through a PMA or HDE during the Covid-19 public health ...
FDA General
Latest FDA Warning Letters
FDA releases its latest batch of Warning Letters that includes Altaire Pharmaceuticals and Samchundang Pharm.
Medical Devices
FDA Clears Smart Medical G-Eye Colonoscope
FDA clears a Smart Medical Systems 510(k) for the G-Eye Colonoscope.
Human Drugs
ICH Guidelines for Exposure to 3 Solvents
FDA releases a draft ICU guideline of permitted daily exposure to three solvents.
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Federal Register
Guidances Post for Covid-19 Emergency
Federal Register notice: FDA makes available guidance documents related to the Covid-19 (XXX U/lc XXX) public health emergency.
Human Drugs
Covid Drug Compounding Guidances Updated
FDA announces updates to two guidances addressing drug compounding during the Covid-19 public health emergency.
