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…
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’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…
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 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…
If your organization still treats audit season like a fire drill scrambling to pull evidence, patch gaps, and cross fingers you’re not alone. But you are falling behind. Continuous control monitoring (CCM) has gone from a “nice-to-have” to a “must-have.” Regulators expect it. Auditors look for it. And the companies…
Understand SEC Rule X’s $50B finance sector impact: regulatory drivers, climate risk disclosures, business costs, penalties, and compliance best practices.
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.
