Canada Wants Data on 200 Chemicals. The Hard Part May Be Finding It Across Your Supply Chain
Canada launches mandatory CEPA section 71 reporting for 200 priority substances, with Phase 1 responses due March 3, 2027.
A Clear IV Solution Can Still Carry a Serious Quality Risk
Baxter recalls two saline lots for potential fiberglass particulate contamination, raising injectable particulate-control questions
An FDA Approval Does Not Automatically Mean Two Drug Products Are Interchangeable
TL;DR Why This Matters Two products can contain the same active ingredient. Both can be FDA approved. They can even look like obvious substitutes. And FDA still may not consider them therapeutically equivalent. That distinction matters because Orange Book TE codes influence how pharmacists, state systems and healthcare professionals think…
Your Test Report Is Current. Is the Standard Behind It Still Current?
TL;DR What FDA Changed FDA’s Recognition List Number 066 modifies the list of voluntary consensus standards it recognizes for use in medical-device regulatory work. The Federal Register notice explains that manufacturers may use recognized standards and declarations of conformity to help address certain premarket requirements. CDRH listed the update among…
The Software Updated Successfully – did the Patient’s Alarm Settings Survive?
TL;DR FDA says GE reported that during an update of Portrait Core Services software, some patients monitored using Portrait Mobile devices were discharged removed from the monitoring system. FDA also says alarm settings may reset to factory defaults following the update. That creates the possibility that the hardware appears operational…
FDA finalizes type VII veterinary master file guidance
FDA’s Center for Veterinary Medicine finalized guidance in August 2026 explaining the use of Type VII Veterinary Master Files for research, development and certain risk reviews involving advanced veterinary technologies. The guidance is especially relevant to: The value is not simply a new file type. The important point is when…
One Manufacturing Change, Ten Countries, Ten Reviews? EMA Is Testing Another Way
EMA published new practical guidance on August 13, 2026 explaining how pharmaceutical companies can participate in pilots where national authorities rely fully or partially on EMA’s assessment of post-authorisation changes. The potential prize is substantial: fewer duplicated technical reviews and faster global implementation of approved changes. But reliance does not…
FDA Just Finalized How Sponsors Should Prepare for Formal Meetings
FDA published final guidance on August 13, 2026 covering formal meetings between FDA and sponsors or applicants of products subject to the Prescription Drug User Fee Act. It applies to drug and biological products regulated by CDER and CBER and finalizes the draft issued in September 2023. This is guidance,…
FDA May Move Digital Breast Tomosynthesis From PMA to 510(k)
FDA has proposed reclassifying digital breast tomosynthesis (DBT) systems from Class III to Class II. If finalized, the change would replace the current PMA framework for these systems with Class II special controls plus 510(k) premarket notification requirements. For manufacturers, this could materially change both new-product submissions and lifecycle-management strategy.…
EMA’s Latest IDMP/PMS Update Is Really a Data-Governance Issue
EMA updated several Product Management Service/ISO IDMP implementation documents on August 12, including Chapter 3 covering the electronic submission and maintenance of medicinal-product information. For marketing authorization holders, this is less a “new regulation” story than a regulatory-data-governance story. The updated Chapter 3 is Version 3.7. EMA says this version…