FDA Calls Out “Egregious” Novartis Petition; Firm Asks Agency To Be Nicer
After the agency reproaches Novartis for what it called a tardy petition seeking to block generic versions of Reclast, the firm offers more information, not in an effort to get FDA to change its mind, but just to change its tone.
You may also be interested in...
FDA posts non-compliance letters and responses from three sponsors that failed to meet deadlines for submitting reports for trials of four drugs in children; more than 70 firms have had their deadlines extended.
Operation Warp Speed confirmed the necessity of having a facility on hand to develop and manufacture a vaccine for the next crisis, the outgoing advisor says.
Broader use of adaptive trial designs and master protocols, checklist-based application review, and enhancement of real-world monitoring of products are among the recommendations of US FDA's COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) report, an effort months in making based on interviews with agency management, staff, and outside stakeholders.