Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Akeso, Algernon, Alnylam, Aurinia, Cytrx, Expression, Hansa, Kala, Neurobo, Novaremed, Orphazyme, Qurient, Rockwell, Sino, Takeda, Zealand.
The U.S. FDA reported that 28 serology tests for antibodies for the SARS-CoV-2 virus either have been withdrawn from the market by the sponsor or delisted by the agency for failure to comply with its notification process for emergency use authorization (EUA). The agency said the list of unavailable tests will be updated over time. For his part, Commissioner Stephen Hahn said the move was undertaken “to ensure that Americans have access to trustworthy tests.”
PERTH, Australia – Perth-based regenerative medicine company Orthocell Ltd. has submitted a 510(k) application to the U.S. FDA for its Celgro collagen medical device for dental guided bone and soft tissue regeneration applications. The submission follows positive results from an FDA-guided bone regeneration study, which is a key component toward the goal of gaining U.S. marketing approval.
Sunovion Pharmaceuticals Inc.’s apomorphine sublingual film (APL-130277), a dopamine agonist the company will market as Kynmobi, has won FDA approval for the acute intermittent treatment of motor fluctuations (off episodes) associated with Parkinson’s disease.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Astrazeneca, Beigene, Bluebird, BMS, Daiichi, Evofem, Geron, Intercept, Orphazyme, Sunovion.
The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.