Breast Ultrasound Recs May Not Be Targeting the Right Women (MedPage Today)
The Afterlife Of Pear Therapeutics: Korean DTx Maker Discusses Vision For Salvaged Migraine Assets (MedTech Insight)
Minute Insight: Merit Adds Dialysis and Biopsy Products For $132.5m (MedTech Insight)
Hospitals are testing AI to communicate with patients. They still don’t know how to talk to them about it (STAT)
Government, Regulatory & Legal
Supreme Court’s False Claims Ruling Leaves Plenty to Litigate (Bloomberg)
Jury in Bard mesh trial won't hear about 2011 factory fire, judge rules (Reuters)
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.
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The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has released a revised guide for inspectors and the pharmaceutical industry outlining the general principles of qualification and validation studies in pharmaceutical manufacturing facilities.
Drug, regulatory, and laboratory animal testing groups want the US Food and Drug Administration (FDA) to ensure flexibility in choosing when to rely on animal testing and when other forms of data may be sufficient for cancer drug safety studies.