JD Supra58m
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
BioSpace1h
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 ...
BioSpace3h
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, ...
Applied Therapeutics, Inc. Sued for Securities Law Violations – Investors Should Contact Levi & Korsinsky for More Information – APLT
NEW YORK, NY / ACCESSWIRE / January 6, 2025 / If you suffered a loss on your Applied Therapeutics, Inc. (NASDAQ:APLT) investment and want to ...
Oculis Trial Shows Potential for Optical Neuroprotective Therapy
By Karen Roman Oculis Holding AG (Nasdaq: OCS) said Phase 2 of its neuroprotective candidate OCS-05 met key endpoints of ...
FiercePharma20h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
STAT21h
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...