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Trump Appointed Martin Makary Targets Faster Drug Approvals With FDA Artificial Intelligence Overhaul
FDA will implement a secure generative AI system across all centers by June 30, aiming to streamline internal reviews and ...
New FDA Leadership Could Raise The Bar For Drug Approvals
A former critic of FDA and Pharma will now oversee the regulation of costly and complicated biologics like vaccines, gene therapies, and blood supply.
FDA grants accelerated approval to avutometinib, defactinib combination
On May 8, the Food and Drug Administration granted accelerated approval to the combination of avutometinib and defactinib for ...
The Manila Times14h
MeiraGTx Granted FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for AAV-GAD for the Treatment of Parkinson's Disease
This RMAT designation is based on data from 3 clinical studies demonstrating the potential benefit of AAV-GAD as a one-time treatment for Parkinson's disease - RMAT designation includes the benefits ...
PharmExec16h
How External Control Arms are Improving Clinical Trials: Q&A with Sujay Jadhav
The use of RWD data in place of placebo groups is improving various elements across the clinical trial space.