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 ...
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 Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Congenital Hyperinsulinism
Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...
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, ...
Contract Pharma1d
Cryoport’s MVE Biological Solutions Registers Mfg. Facilities with FDA
Adheres to requirements, including 21 CFR Part 820 and Good Manufacturing Practices.
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
TMCnet1d
Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the U.S. Food and Drug Administration ("FDA")
To meet the standards of FDA-registered facilities, MVE adheres to stringent requirements, including but not limited to 21 ...
The National4d
UK’s first drug consumption room to open later this month
The first safe drug consumption room in the UK will open in Glasgow on January 13, the council has confirmed. The facility will allow drug users to take illegal substances under medical supervision ...
News246d
WATCH | A former Tembisa drug addict sets up recovery centre, helping others in his community
After years of struggling with substance addiction, two years into his recovery, Thato Matome is using his struggles to help better his community.