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to queries about 510(k) filings within 180 days will lead to an assumption on the agency’s part that the applicant has withdrawn the submission.
Building on years of informal collaboration, the American Society of Clinical Oncology (ASCO) and the World Health Organization (WHO) said they plan to measure and improve cancer care an equity gap of cancer care around the world.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Applied, J Ints, Legend.
The International Medical Device Regulators Forum (IMDRF) has posted a draft guidance for cybersecurity practices for legacy devices, a nod to the number of older devices that are difficult to secure. This document is a follow-up to a standing IMDRF guidance that spans the product life cycle, but which apparently left stakeholders with a few questions.
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