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Home » Topics » Regulatory

Regulatory
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Regulatory actions for Dec. 1, 2022

Dec. 1, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Enovis, Hemosonics, Wise.
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Regulatory actions for Dec. 1, 2022

Dec. 1, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ananda, Aum, First Wave, Lobe, Nova Mentis, Regeneron, Sensorion, Transcode, Vistagen.
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PIE Act reintroduced in US House of Representatives

Nov. 30, 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.
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European Union flag

EU states working around MDR issues, but the scope of solutions remains fragmented

Nov. 30, 2022
By Mark McCarty
A variety of governmental entities in the EU are feeling pressure to address the issues with the rollout of the Medical Device Regulation, and some EU member states have taken matters into their own hands.
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Regulatory actions for Nov. 30, 2022

Nov. 30, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Egg Medical, Electromed, Pulmonx, Surgibox, Treace Medical Concepts.
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Regulatory actions for Nov. 30, 2022

Nov. 30, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Ascletis, Buchang, Capstone, Caribou, Genentech, Gilead, Kala, Novavax, Remd, Sofie.
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Former PTO commissioners come out in support of latest US Senate push for patent reform

Nov. 29, 2022
By Mark McCarty
U.S. Supreme Court case law on patent subject matter eligibility has provoked several attempts by Congress to rewrite the statute, but there are lingering concerns about the latest proposal, the Patent Eligibility Restoration Act of 2022. Among these concerns is that the revised set of exceptions to subject matter eligibility might take time to work through both in terms of litigation and patent prosecution, but the bill has the support of a number of stakeholders, including two former commissioners of the U.S. Patent and Trademark Office (PTO).
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Pill with British pound sign

BIA rallying biopharma to oppose changes to UK tax credit system

Nov. 29, 2022
By Nuala Moran
The U.K. Bioindustry Association (BIA) is in an eleventh hour fight against changes to R&D tax breaks that it estimates will result in a £400 million to £800 million (US$480 million to $960 million) cut in payments to the sector. The changes will see cash credit claims reduced from 14.5% to 10%, cutting payments from 33 pence per £1 of spend to 18.6 pence per pound of spend from April 2023. Along with other tweaks, this is an effective 50% cut for biopharmas that do not pay any corporation tax because they are loss-making.
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FDA Approved stamp with blister pack

US approvals and global regulatory activity at lowest point this year

Nov. 29, 2022
By Karen Carey
As the days have grown darker throughout November, global regulatory activity and U.S. approvals have continued to drop, marking the month as the slowest of 2022. Compared with this time last year, regulatory news is down by 9% and FDA approvals are down by a quarter. On top of that, new molecular entity clearances in the U.S. are at a six-year low.
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World map with supply chain icons

Countdown begins for US track-and-trace requirements

Nov. 29, 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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