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Home » Topics » Regulatory

Regulatory
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Immuno-oncology

Vittoria’s VIPER-101 CAR T-cell therapy cleared to enter clinic for T-cell lymphoma

Dec. 11, 2023
Vittoria Biotherapeutics Inc. has received FDA clearance of its IND application to initiate a first-in-human phase I trial with VIPER-101, a gene-edited, autologous, chimeric antigen receptor (CAR) T-cell therapy for treatment of patients with relapsed or refractory T-cell lymphoma.
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Sickle cells

US FDA approves first CRISPR-based gene therapy Casgevy for sickle cell; Lyfgenia gets nod, too

Dec. 8, 2023
By Karen Carey and Mari Serebrov
Both Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) and Bluebird Bio Inc.’s Lyfgenia (lovotibeglogene autotemcel, lovo-cel) received U.S. FDA approval Dec. 8, providing 16,000 American sickle cell patients who have recurring vaso-occlusive events with access to the first cell-based gene therapies.
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U.S. White House

‘Oh when the government goes marching in’ a rising US threat?

Dec. 8, 2023
By Mari Serebrov
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices.
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Biospectal Optibp smartphone app

Biospectal receives CE mark for blood pressure monitoring app

Dec. 8, 2023
By Shani Alexander
Biospectal SA has received a CE MDR class IIa medical device certification for its optical fingertip blood pressure monitoring app, Optibp. The device records fingertip blood flow optically and transforms the information into a pulse wave that it analyzes to estimate blood pressure.
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Regulatory actions for Dec. 8, 2023

Dec. 8, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioporto.
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2023 FDLI Enforcement Conference

FDA facing a ‘somewhat unimaginable’ volume of applications for LDTs

Dec. 8, 2023
By Mark McCarty
The U.S. FDA’s draft rule for lab-developed tests (LDTs) has proven to be every bit as controversial as expected, although the controversy is only marginally about the workload that would come with rulemaking.
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‘Oh when the government goes marching in’ a rising US threat?

Dec. 7, 2023
By Mari Serebrov
After a nine-month review, the Biden administration is preparing to go where all other U.S. administrations have refused to trod. In releasing a draft framework to help federal agencies decide whether to exercise a federal march-in on patent rights protecting taxpayer-supported drugs and other inventions, including medical devices, the Department of Commerce’s National Institute of Standards and Technology included price as a factor in considering whether a product is “reasonably” available, as required under the 1980 Bayh-Dole Act.
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2023 FDLI Enforcement Conference

Post-pandemic inspection load an ongoing struggle for FDA

Dec. 7, 2023
By Mark McCarty
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
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Gears with regulatory words
2023 FDLI Enforcement Conference

FDA tells industry to get serious about UDI compliance

Dec. 7, 2023
By Mark McCarty
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas addressed an audience at the Food and Drug Law Institute’s annual enforcement conference here in the nation’s capital, acknowledging that the proposed alignment of the Quality System Regulation – also known as Part 820 – with ISO 13485 is no light lift.
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Regulatory icons
2023 FDLI Enforcement Conference

Abiomed warning letter for final deviation seen as opening salvo

Dec. 7, 2023
By Mark McCarty
The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.
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