Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Lumiradx, Proscia.
The U.S. FDA’s device center continues to promote alternatives to ethylene oxide (EtO) as a medical device sterilant, with the latest development involving radiation as a sterilizing technology. The agency said it may open a new master file program for radiation that follows an existing program that is agnostic as to sterilization method, and which may speed the adoption of alternative sterilization methods in the years ahead. The FDA’s Center for Devices and Radiological Health recently announced a pilot program for alternatives to EtO sterilization that would eliminate a significant number of regulatory filings.
Abbott Laboratories received FDA clearance for its Freestyle Libre 3 continuous glucose monitoring system (CGM) just before the kickoff of the American Diabetes Association (ADA) annual meeting June 3 followed by breakthrough device designation for a combined CGM and continuous ketone monitoring system.
Global regulatory activity has fallen slightly, partially due to a decline in pandemic activity, and U.S. FDA approvals of drugs and biologics are at their lowest levels in five years.
The U.S. FDA’s accelerated approval path is front burner these days, what with Congress looking to modernize the path through provisions added to the must-pass user fee legislation, the controversy still boiling over the FDA’s accelerated approval last year of Biogen Inc.’s Alzheimer’s drug, Aduhelm (aducanumab), and a number of recent withdrawals of drugs granted accelerated approval years ago.
Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada.
Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
The U.S. FDA’s guidance for electromagnetic compatibility (EMC) in medical devices has several moving parts, a consequence of the fact that the scope included cardiac electrophysiology devices and non-implantable medical devices. For the most part, the terms of the guidance will go into force within 60 days, but the compliance deadline for in vitro diagnostics (IVDs) doesn’t go into force until June 6, 2023, giving these manufacturers much more breathing room than their non-IVD counterparts.
The U.S. FDA determined that the pandemic required an adjustment to applicant turn-around times for the agency’s responses to regulatory filings, an allowance that was unavoidable given the impact of the pandemic on applicants’ ability to respond. That policy has now been reversed, the agency said, which means that a failure to respond to queries about 510(k) filings within 180 days will lead to an assumption on the agency’s part that the applicant has withdrawn the submission.
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