Latest From Brenda Sandburg
At ASCO symposium on cancer care during the pandemic, NCI Director Ned Sharpless notes trial accrual at NCI's National Clinical Trials Network dropped by half in March and April.
COVID-driven supply shortages were both the cause of and solution to production deficiencies for manufacturers of neuromuscular blocking agents; US FDA is permitting Mylan, Gland, and Fresenius Kabi to distribute vecuronium bromide and rocuronium bromide even though they do not have the ‘paralyzing agent’ warning on the caps since the products are in high demand at ICUs. The appropriately embossed caps were unavailable due to supply chain disruptions caused by the pandemic.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Medical and advocacy groups claim FDA is requiring women to fill prescriptions for Mifeprex in person while waiving REMS requirement for in-person visits for other drugs.
Proposed rule would eliminate petitioner advantage when patent board is deciding whether to institute inter partes review of patent claims.
USPTO pilot program aims to examine applications for COVID-19 products subject to approval by FDA within 6 to 12 months. Prioritized examination is available solely for small entities and would save them $2,000.