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Regulatory
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Regulatory actions for Nov. 22, 2023

Nov. 22, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Baird Medical.
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US FTC hits gene testing firm for claims related to ancestry testing

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
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US FTC seeks yet more broad AI investigative authority

Nov. 22, 2023
By Mark McCarty
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
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Laptop displaying FDA logo

FDA clears 4dmedical’s CT lung ventilation analysis software

Nov. 22, 2023
By Tamra Sami
The U.S. FDA cleared respiratory imaging technology company 4dmedical Ltd.’s computed tomography lung ventilation analysis software (CT LVAS) that is nearly identical to its X-ray velocimetry technology but uses CT imaging and provides greater access to the four-dimensional imaging technology.
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Polaris begins rolling BLA for ADI-PEG 20 for pleural mesothelioma

Nov. 21, 2023
By Tamra Sami
Polaris Pharmaceuticals Inc. has submitted the first part of its rolling BLA to the FDA for lead product, ADI-PEG 20, for systemic treatment of patients with malignant pleural mesothelioma with non-epithelioid histology in combination with a platinum agent and pemetrexed. The BLA is supported by the pivotal phase III Atomic study in which pegargiminase (pegylated arginine deiminase/ADI-PEG 20) met the primary endpoint of a statistically significant improvement in overall survival and the secondary endpoint of a significant improvement in progression-free survival in patients with malignant pleural mesothelioma.
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Rexulti television ad

FDA chides Otsuka for making false or misleading claims in Rexulti advertising

Nov. 21, 2023
By Tamra Sami
The U.S. FDA’s Office of Prescription Drug Promotion is calling out Otsuka Pharmaceutical Co. Ltd. for making “false or misleading claims and representations about the efficacy of Rexulti” in a television advertisement.
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Regulatory actions for Nov. 21, 2023

Nov. 21, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Foundation Medical, GE Healthcare, Medtronic, Pixyl, Supira Medical.
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Cardinal Health Monoject Disposable Syringes

FDA cautions against Cardinal Health Monoject syringe use

Nov. 21, 2023
By Mark McCarty
The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.
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Laptop displaying FDA logo

FDA predetermined change control program major shift for med-tech

Nov. 21, 2023
By Mark McCarty
The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.
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Cross section illustration of HIV virus parts
HIV/AIDS

Arenaviral therapeutic vaccine HB-500 gets IND clearance for HIV

Nov. 21, 2023
Hookipa Pharma Inc. has received clearance from the FDA for its IND application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.
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