Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Beigene, Novartis, TG.
The FDA has granted an emergency use authorization (EUA) to Inspect IR Systems LLC, of Frisco, Texas, for the company’s namesake test that evaluates the patient’s breath for the presence of volatile organic compounds (VOC) indicative of the SARS-CoV-2 virus. The test is expected to increase the volume of testing by only 64,000 per month at the current rate of production, however, making this a technological breakthrough of limited impact on the COVID-19 pandemic.
In its first report on device application processing times since it completed most of its medical device reforms, Australia’s Therapeutic Goods Administration (TGA) met all the legislated time frames for processing medical device applications during the six-month period from July 31 to December 2021.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bendit Technologies, Sonoscape Medical.
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amneal, Astellas, Coherus, Innovent, Inxmed, Merck, PTC, Regeneron.
The FDA’s June 2021 draft guidance for remanufacturing of medical devices wades into a highly complicated area of compliance for third-party servicing organizations that may not be familiar with FDA regulations, but the draft has sparked another set of concerns. Two trade associations said the draft would seem to suggest that original equipment manufacturers (OEMs) must disclose confidential trade secrets to give these third parties the information needed to service these devices, a suggestion that both the Medical Device Manufacturers Association (MDMA) and the Advanced Medical Technology Association (AdvaMed) said is clearly out of bounds.
The U.S. FDA’s safety and performance-based pathway (SPBP) is intended as a leaner, meaner alternative to the conventional 510(k) pathway that would sidestep some of the presumed problems with the concept of substantial equivalence. The agency recently added four device types to this program, including orthopedic fracture fixation plates.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fosun Diagnostics.
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