TL;DR What Happened? The recalled product is Baxter 0.9% Sodium Chloride Injection USP, 500 mL VIAFLEX Plastic Container, involving identified lots distributed July 31 through August 3 to multiple U.S. states. The company says the potential contaminant was identified as fiberglass. Customers should discontinue use and return affected units. Why…
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…
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…
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 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 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…
FDA’s 4th draft guidance revision streamlines biosimilar PK testing, allowing non-U.S. comparators with analytical justification to cut $20M costs and speed approvals.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.
Learn new requirements of FDA QMSR implementation: How to align with ISO 13485, bridge gaps in records/labeling, prepare for risk-based inspections, and avoid shutdown risks.
