draft guidance – Talk Bio

Actionable Insights Powered by AI

Spotlight On: It’s Raining AI Devices as Regulatory Storm Reshapes Digital Health

2 weeks ago talkbio0Tagged 2025, Accountability, AI-enabled, clinical oversight, digital health regulation, digital mental health devices, draft guidance, EU, EU AI Act health, Generative AI, Health care facility, Medical Devices, Regulation, Software as a Medical Device, United States Food and Drug Administration

AI-enabled medical devices; digital health regulation 2025; FDA AI draft guidance; EU AI Act health; generative AI in healthcare; SaMD regulation; clinical oversight of AI; AI accountability in healthcare; digital mental health devices

FDA Unveils Long-Awaited Biosimilar Guidance to Accelerate Approvals and Cut Costs

2 months ago talkbio0Tagged Biopharmaceuticals, biosimilar guidance, biosimilarity, Clinical Research, Comparative Efficacy, draft guidance, Drug Costs, four-letter suffix, naming convention, United States Food and Drug Administration

FDA; biosimilar guidance; 2025 draft guidance; comparative efficacy study; analytical assessment; four-letter suffix; naming convention; biosimilarity; drug costs; biologic medicines