The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
The Drugs Controller General of India has granted Novavax Inc. and the Serum Institute of India Pvt. Ltd. emergency use authorization (EUA) for Novavax’s protein-based COVID-19 vaccine. It was authorized for use in adolescents aged 12 to 18 years. The vaccine will be manufactured and marketed in India by the Serum Institute under the brand name Covovax.
As congressional scrutiny of the U.S. FDA’s accelerated approval path continues, the agency is focusing research efforts into appropriate disclosure on direct-to-consumer websites about a drug’s accelerated approval and the status of confirmatory trials. Previous research by the FDA’s Office of Prescription Drug Promotion (OPDP) found that 27% of DTC websites providing information about a drug with accelerated approval don’t disclose that the products are on the market through accelerated approval.
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.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Catalyst Orthoscience.
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.
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.
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.
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.
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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