The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA comments on two patent term extensions; Comment period reopened on Orange Book patents.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Check-Cap, Fujifilm, Olympus Medical, Pelican Diagnostics.
While World Trade Organization members continue to debate a proposal to waive intellectual property rights for COVID-19 vaccines and therapies, Biolyse Pharma Corp. is threatening to apply for a compulsory license of Johnson & Johnson’s one-dose vaccine through the Canadian Access to Medicines Regime.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioxcel, Calliditas, Histogen, Melinta, Oryzon, Pharmaessentia, Tetra.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA launches EUA safety dashboard; Fed Circuit claims mandamus jurisdiction in IPR institution; Comment period reopened on Orange Book patents.
Most of the med-tech companies doing business during the COVID-19 pandemic are experienced and already have their FDA compliance systems in place. However, Dennis Gucciardo, a partner at the D.C. office of Morgan, Lewis & Bockius LLP, told BioWorld that while the FDA will give industry sufficient time to transition their emergency use authorizations (EUAs) to conventional premarket filings, the cost of setting up a quality management system may be greater than some current EUA holders are willing to bear.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA announces recall of infusion sets; Recall announced for Roche testing systems; NIH announces technique for improved photoreceptor imaging.
Remegen Co. Ltd.’s RC-18 (telitacicept) was granted conditional approval for systemic lupus erythematosus (SLE), marking the first NDA approval for the company that launched the world’s biggest biotech IPO last year.