JD Supra4h
MoCRA Guidance Update for Registration and Listing of Cosmetic Product Facilities and Products
What Happened: The Food and Drug Administration (FDA) released new guidance regarding the registration and listing of ...
gasworld4h
Cryoport secures FDA registration for MVE manufacturing facilities
Temperature-controlled supply chain solutions firm Cryoport has registered all three of its MVE Biological Solutions (MVE) ...
RESTEM Receives FDA Fast Track Designation for Restem-L for Idiopathic Inflammatory Myopathy
L, a lead ULSC program, following the recent Orphan Drug Designation • Recently reported Phase 1 data of Restem-L demonstrated a clinically meaningful efficacy and significant reduction in steroid use ...
Rezolute receives BTD from FDA for ersodetug in treatment of hypoglycemia
Rezolute (RZLT) announced that the U.S. Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, to ersodetug, ...
BioSpace8h
FDA’s New AI Guidance Highlights Risks of Technology, Urges Early Sponsor Engagement
The FDA’s guidance on AI in drug development points to potentially life-threatening consequences of the technology, ...