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FDA Approved seal

Three NMEs added, but US approvals are at five-year low

June 7, 2022
By Karen Carey
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.
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Magnifying glass, FDA concept image

US FDA’s accelerated approvals: Time to reform?

June 7, 2022
By Mari Serebrov
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.
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Novavax logo, coronavirus vaccine vials

Novavax COVID-19 vaccine wins adcom support

June 7, 2022
By Mari Serebrov
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.
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Investigation into questionable investments prompts executive re-shuffle at China’s Cstone

June 7, 2022
By Tamra Sami
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.
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Regulatory actions for June 7, 2022

June 7, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acer, Amgen, Antengene, Aum, Biocryst, Biondvax, BMS, Clarity, Cstone, Enlivex, GBT, Iaso, Innovent, Lexaria, Pfizer, Revive, Senhwa, Sensorion, Sifi, Veru.
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Hand holding FDA blocks

Final FDA guidance for electromagnetic compatibility offers one-year delay for IVDs

June 6, 2022
By Mark McCarty
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.
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FDA’s device center drops response pause policy for premarket submissions

June 6, 2022
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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Minding the gap: ASCO and WHO focus on improving global cancer care

June 6, 2022
By Lee Landenberger
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.
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Regulatory actions for June 6, 2022

June 6, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aurora Spine.
Read More

Regulatory actions for June 6, 2022

June 6, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Applied, J Ints, Legend.
Read More
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