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Regulatory
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Hand holding FDA blocks

Device makers back in FDA’s warning letter crosshairs

March 11, 2022
By Mark McCarty
The list of FDA warning letters in recent months has conspicuous in its absence of letters to device makers, but that trend has reversed with three warnings posted March 8, including a warning letter to Cardioquip LLC.
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Hand places Infrascanner device on patient's head

Infrascan wins FDA clearance for device to diagnose traumatic brain hemorrhage in children

March 11, 2022
By David Godkin
Developed by Infrascan Inc., the FDA-cleared Infrascanner device was touted as the first hand-held device to help detect bleeding in the skull and supported financially by the U.S. military anxious to treat moderate to severe traumatic brain injury in wounded service members. The FDA has now expanded the Infrascanner’s use to traumatic intracranial hematomas or brain bleeds in pediatric patients aged 2 years and older.
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Rika plasma donation system

FDA clears Terumo plasma collection device

March 11, 2022
By Catherine Longworth
The FDA has cleared a plasma collection device developed by Terumo Blood and Cell Technologies (Terumo BCT) and plasma collection network CSL Plasma. The companies, which are subsidiaries of Terumo Corp. and CSL Ltd., signed a collaboration deal in 2021 to develop the new Rika device for CSL Plasma collection centers. The automated technology is designed to reduce plasma collection time to 35 minutes or less. According to the Red Cross, plasma donations currently take on average about 1 hour and 15 minutes.
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Regulatory actions for March 11, 2022

March 11, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Philips.
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Three China firms named to US SEC list under HFCAA

March 11, 2022
Three U.S.-listed China-based biopharmas were among five companies named this week by the U.S. SEC for reportedly failing to submit necessary accounting reports under the Holding Foreign Companies Accountable Act (HFCAA).
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Chinese flag, pills

China NMPA speeds up NDA reviews to encourage new drug development

March 11, 2022
By Doris Yu
The NMPA’s Center for Drug Evaluation (CDE) published a draft document named the Pilot Work Procedure to Speed Up the Review of Innovative Drug NDAs in February 2022. It aims to accelerate the review of new drug applications (NDAs) in China.
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Regulatory actions for March 11, 2022

March 11, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allogene, Antengene, Atyr, Immutep, In3bio, Intellia, Pharmazz, Quoin, Samsung Bioepis, Selecta, Servier, TG, Tracon.
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Cloud/cybersecurity illustration

FDA says PTC Axeda software vulnerabilities affect wide range of medical devices

March 10, 2022
By Mark McCarty
The U.S. FDA has issued an advisory regarding vulnerabilities identified in the Axeda line of remote access software published by PTC Inc., which may affect more than 100 products made by dozens of manufacturers. The vulnerability could allow a hacker to trigger changes in the operation of the affected devices, a massive risk to patients undergoing medical imaging and radiotherapy procedures. The FDA notice stated that the Axeda Agent and desktop server programs are the subject of a notice by the Cybersecurity & Infrastructure Security Agency (CISA), which characterizes the vulnerability as requiring only a low-complexity attack to exploit.
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TGA: More feedback needed on repurposing drugs

March 10, 2022
By Mari Serebrov
Given the challenges in repurposing medicines, Australia’s Therapeutics Goods Administration (TGA) opened a second consultation on the subject March 10.
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Quoin collecting EMA tips on NS path as efforts in other quarters roll on

March 10, 2022
By Randy Osborne
Quoin Pharmaceuticals Ltd.’s scientific advice briefing document is asking the EMA for ideas on how to proceed with lead asset QRX-003 for Netherton syndrome (NS).
Read More
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