Health Canada now expects covered clinical trials to be registered within 21 days of first participant enrollment and summary results to be disclosed within 12 months of primary study completion. Here is what sponsors should change—and one important detail about what is guidance versus law.
TGA publishes new guidance for hospitals implementing UDI across inventory, clinical systems, patient records and recalls.
FDA testing finds undeclared fluoxetine and toxic DNP in Lipofit Extreme Fat Burner 2.0, triggering a nationwide consumer recall.
Canada launches mandatory CEPA section 71 reporting for 200 priority substances, with Phase 1 responses due March 3, 2027.
Baxter recalls two saline lots for potential fiberglass particulate contamination, raising injectable particulate-control questions
FDA Recognition List 066 changes recognized medical-device standards. Manufacturers should check active protocols and submissions.
FDA warns that GE Portrait software updates can remove monitored patients and reset alarm settings, creating a clinical change-control risk.
FDA’s 4th draft guidance revision streamlines biosimilar PK testing, allowing non-U.S. comparators with analytical justification to cut $20M costs and speed approvals.
Explore why 76% of healthcare AI pilots stall due to regulatory gaps in HIPAA, EU AI Act, FDA rules. Learn compliance strategies and governance best practices for safe scaling.
Explore how Vinay Prasad’s resignation from FDA’s CBER amid regulatory clashes disrupts pharma profits, rare disease approvals, and vaccine strategies. Analyze impacts, compliance shifts, and future enforcement.
