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 ...
BioSpace5h
When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...
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, ...
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 ...
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 ...
DOT takes heat for drug testing certification delays
A proposed rule to temporarily require drug testing urine samples is getting pushback from facilities that have invested in ...
New Santa Ana7d
An inmate arrested on drug charges died at the Theo Lacy Facility in Orange
On Sunday, Dec. 29, 2024, an inmate housed at the Theo Lacy Facility in Orange died. 45-year-old Anthony Creston Brown of ...
Orange County Register11d
New bill seeks to limit clustered drug rehab centers in residential areas
Newly-filed legislation could change how drug and alcohol rehabilitation facilities are regulated in residential ...
JD Supra12d
FDA Seeks Comments on Updates to MoCRA Guidance on Registration, Listing of Cosmetic Product Facilities
On December 11, 2024, the US Food and Drug Administration (FDA) updated its Guidance for Industry: Registration and Listing of Cosmetic ...