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Home » Topics » Regulatory

Regulatory
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FDA divisions to develop pilot for companion diagnostic performance criteria

Nov. 23, 2022
By Mark McCarty
The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence, said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well.
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PIE Act reintroduced in U.S. House of Representatives

Nov. 23, 2022
By Mark McCarty
The U.S. House of Representatives has resurrected the Pre-approval Information Exchange (PIE) Act, a bill that would bolster the prospects for drugs and devices by improving communications with payers prior to U.S. FDA clearance or approval of the product. The supporters of the legislation, a bipartisan group of members of the House Energy and Commerce (E&C) Committee, see the legislation as essential as a means of overcoming some of the ambiguities in a 2018 FDA guidance pertaining to communications between manufacturers and payers, and thus a replay of one of the more interesting methods of critiquing an FDA guidance.
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Rapidai ICH platform eliminates false positives, targets smaller intracranial hemorrhages

Nov. 23, 2022
By David Godkin
Rapidai Inc. received U.S. FDA 510(k) clearance for release of intracranial hemorrhage (ICH) triage technology that reduces notification fatigue in doctors swamped by calls to treat hemorrhages that turn out to be false positives. In a test sample sent to the regulatory agency, the artificial intelligence (AI)-powered system demonstrated a sensitivity rating of 97% detecting genuine hemorrhages and 100% specificity for a false positive rate of zero.
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China in red on globe

Microport’s intracranial artery stent granted priority review in China

Nov. 23, 2022
By Doris Yu
Microport Neurotech Ltd.’s intracranial visualized stent Rebridge has been included in the green channel, a priority review for medical devices, by China’s NMPA.
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EU flag, map, charts

EU breaking boardroom glass ceiling

Nov. 23, 2022
By Mari Serebrov
After shelving it for the past decade, the EU Parliament this week adopted a directive forcing large publicly listed companies to break the glass ceilings that have allowed a men-only mentality to thrive in corporate boardrooms across much of Europe. The so-called Women on Boards Directive, formally adopted Nov. 22, will require EU-based public companies to have women in at least 40% of their nonexecutive director posts or 33% of all director posts by the end of June 2026. Companies with fewer than 250 employees will be exempt.
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Regulatory actions for Nov. 23, 2022

Nov. 23, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Empatica, Lucira Health.
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Red blood cells, DNA

The FIX is in: Uniqure NAbs FDA clearance for gene therapy Hemgenix in hemophilia B

Nov. 23, 2022
By Randy Osborne
The U.S. FDA gave its go-ahead for Hemgenix (etranacogene dezaparvovec-drlb), Uniqure NV’s one-time gene therapy – the first for the treatment of adults 18 and older living with hemophilia B. Patients have been waiting “maybe beyond two decades” for a new therapy, Uniqure CEO Matthew Kapusta said. Hemgenix emerged from pioneering work by St. Jude Children’s Research Hospital and the University College London.
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Regulatory actions for Nov. 23, 2022

Nov. 23, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Argenx, Gamida, GSK, Innocare, Intelgenx, Junshi, Marker, Palisade, Regeneron, Revive, Takeda.
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Blood vessels

Bioda’s artificial blood vessel gains NMPA approval, the first in China

Nov. 22, 2022
By Zhang Mengying
Jiangsu Bioda Life Science Co. Ltd.’s artificial blood vessel has gained class III medical devices approval from China’s NMPA, marking the first domestic artificial blood vessel to get such approval. Nantong, China-based Bioda’s vessel is used for aortic coarctation and aneurysms.
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FDA divisions to develop pilot for companion diagnostic performance criteria

Nov. 22, 2022
By Mark McCarty
The companion diagnostic (CDx) has been a mainstay of oncology care for several years, but Richard Pazdur, director of the U.S. FDA’s Oncology Center of Excellence (OCE), said recently in a public forum recently that the notion of a single CDx for an investigational drug has not served patients well. Pazdur said OCE and the FDA’s Center for Devices and Radiological Health are working on a pilot program that would entail the publication of performance standards for the tests used in these trials, a development that would lead to more routine development of lab-developed tests (LDTs) for these studies and thus undercut any incentive to develop a patented in vitro diagnostic for that purpose.
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