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Regulatory actions for March 23, 2022

March 23, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascentage, Atrogi, Calliditas, Cansino, Marinus, Merck, Orphazyme, Palisade, Takeda.
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Regulatory actions for March 22, 2022

March 22, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Catalyst Orthoscience.
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Artificial intelligence and digital health icons

2022 to be the year of draft guidances for AI and machine learning

March 22, 2022
By Mark McCarty
Much of the question of FDA regulation of artificial intelligence (AI) and machine learning (ML) is seen as revolving around changes to the statute, but that does not mean the FDA and other agencies are in wait-and-see mode. Representatives of both the FDA and Health Canada said on a March 22 webinar that guidances related to these algorithms will be posted later this year, thus opening the door to a more predictable premarket path for these products.
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Product recall concept image

Philips Respironics adds V60 ventilators to list of recalled devices

March 22, 2022
By Mark McCarty
Murrysville, Pa.-based Philips Respironics Inc. has had its share of troubles with its devices for respiratory use, including several CPAP machines. The FDA reported March 21 that the company’s V60 and V60 Plus respirators are now the subjects of a class I recall due to the use of an expired adhesive that could ultimately lead to a shut-down of the devices, including instances in which the shut-down would not be accompanied by an alarm.
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Changes in store for US ophthalmic products

March 22, 2022
By Mari Serebrov
Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
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Inspections, IRs fly in the ointment of US biosimilar program

March 22, 2022
By Mari Serebrov
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II.
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Regulatory actions for March 22, 2022

March 22, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aura, Biomarin, BMS, Kye, Neurosense, Oryzon, Provention, Travere.
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Paul Anderson

TGA clears Orthocell’s regenerative nerve repair device

March 21, 2022
By Tamra Sami
Australia’s Therapeutics Goods Administration (TGA) cleared Orthocell Ltd.’s regenerative nerve repair device, Remplir, a biological scaffold that mimics the outer layer of the peripheral nerve to facilitate nerve repair.
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Spaceoar Vue components

Boston Scientific issues urgent field safety notice for Spaceoar systems

March 21, 2022
By Annette Boyle
Boston Scientific Corp. sent warning notices of the potential for embolisms arising from use of its Spaceoar and Spaceoar Vue systems because of “inadvertent placement of Spaceoar gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis.”
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US FDA pondering improvements to drug ingredient database

March 21, 2022
By Mari Serebrov

The U.S. FDA is seeking comments to help it improve the usability of the Center for Drug Evaluation and Research’s Inactive Ingredient Database.


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