Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation
Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.
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BioAsia 2023: Leaders from Novartis, Apple Talk Innovation, Tech, Data Privacy
BioAsia 2023 was a melting pot of ideas with Novartis's CEO and a senior executive from Apple, among others, discussing a range of topics including the potential of novel therapies and platforms such as siRNA and radioligand and also where things were headed as the union of technology and biotech drives new insights into biology and promises to help reimagine healthcare.
ICER Hemophilia Gene Therapy Reviews Show Clear ‘Net Health Benefit’ But Caution On Patient, Payer Fronts Given Upfront Costs
Restrictive interpretations of FDA labels for BioMarin and CSL Behring products by payers could signal slow launch of gene therapies seeking to supplant existing treatments.
Accelerated Approval For Gene Therapies: FDA’s Wilson Bryan Offers A ‘Framework’
Bryan, who oversees reviews of gene and cell therapies in US FDA’s biologics center, cautioned against falling in love with a biomarker when it is showing no ‘clinical effect.’