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Home » Topics » Regulatory

Regulatory
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European Commission eyes a new set of fixes for device shortages under MDR

Nov. 28, 2022
By Mark McCarty
The angst over the maladroit roll-out of the European Union’s Medical Device Regulation (MDR) has reached the European Parliament (EP), which met recently to address the issue. Stella Kyriakides, who oversees the MDR on behalf of the European Commission (EC) responded to stinging criticism from the EP that the EC’s health council will meet in December to address both the short-term and structural problems with the MDR, but had little detail to offer other than a promise to keep the EP abreast of these developments.
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Lung cancer illustration

Affirming advisers, FDA rejects Spectrum lung cancer drug with CRL

Nov. 28, 2022
By Michael Fitzhugh
Spectrum Pharmaceuticals Inc. president and CEO Tom Riga said the company would "immediately deprioritize" its poziotinib program after the U.S. FDA issued a complete response letter (CRL) suggesting the company would have to generate new clinical data prior to potential approval.
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World map with supply chain icons

Countdown begins for US track-and-trace requirements

Nov. 28, 2022
By Mari Serebrov
With only a year to go before 100% compliance with the U.S. Drug Supply Chain Security Act’s serialization provisions will be required from the beginning to the end of the drug supply chain, most biopharma manufacturers are pretty confident they’re ready for the Nov. 27, 2023, deadline. But distributors? Not so much. And they lay the blame at the manufacturers’ feet.
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Regulatory actions for Nov. 28, 2022

Nov. 28, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Anteris, Seekin.
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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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