How “Regulatory Sandboxes” Offer Hope For New Technologies That Don’t Fit The Regulatory Mold (MedTech Insight)
To protect chickens from bird flu, researchers try to CRISPR in immunity (STAT)
The ‘model-eat-model world’ of clinical AI: How predictive power becomes a pitfall (STAT)
How doctors and nurses shape Google’s AI, DEA extends telehealth flexibilities (STAT)
Sanofi adds another AI alliance, this time for biologics with Baidu CEO’s startup (Endpoints)
Clinicians ‘love yet fear’ AI, say medtech leaders (MedTech Dive)
J&J-backed HistoSonics gets de novo clearance for liver cancer treatment (MedTech Dive)
Insulet wins preliminary injunction against EOFlow in patent suit (MedTech Dive)
J&J could reach market-leading medtech growth after consumer spinoff: analysts (MedTech Dive)
Government, Regulatory & Legal
D.C. Court Strikes Down Copay Accumulator Rule (FDA Law Blog)
Connecticut’s comptroller explains his thinking about GLP-1s for state employees (STAT)
Former VA Secretary, Biogen Exec On IRA And Politics, Price Clamps In Europe (Pink Sheet)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
The World Health Organization (WHO) published a draft guidance this month that aims to assist regulators and pharmaceutical companies in integrating environmental sustainability strategies and metrics into pharmaceutical manufacturing.