Human Drugs
ICH Guidelines for Exposure to 3 Solvents
FDA releases a draft ICU guideline of permitted daily exposure to three solvents.
Human Drugs
Repeated CGMP Violations at Altaire
FDA warns Altaire Pharmaceuticals about repeat CGMP violations in its manufacturing of finished drugs.
Federal Register
User Fee Financial Details Virtual Meeting
Federal Register notice: FDA announces a 6/22 virtual public meeting entitled Financial Transparency and Efficiency of the Prescription Drug User Fee ...
Human Drugs
3 CGMP Violations at Koreas Samchundang Pharm
FDA warns South Koreas Samchundang Pharm about CGMP violations in its manufacturing of finished drugs.
Human Drugs
Woodcock Detailed to Commissioners Office
CDER director Janet Woodcock accepts a detail in the Office of the Commissioner to start-up the Trump Administrations therapeutics initiative under it...
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 ...
FDA General
Since Our Last Issue ...
Industry news you may have missed since our last issue.
Human Drugs
Covid Drug Compounding Guidances Updated
FDA announces updates to two guidances addressing drug compounding during the Covid-19 public health emergency.
