2020 Vision For FDA's Sentinel: 'Systemic' Integration Of Surveillance Looms
PDUFA reauthorization agreement sets up fiscal 2020 as milestone for weaving active surveillance into drug review – and for keeping sponsors informed of activities that affect their products.
You may also be interested in...
Omnibus legislation to fund the federal government for FY 2017 includes an increase in non-user fee funds, which should please stakeholders.
In interview with the Pink Sheet, Center for Drug Evaluation and Research director discusses her 30-year career, retirement speculation, and upcoming projects.
The biopharmaceutical industry is hoping the terms set under the negotiations with the FDA for the sixth round of the Prescription Drug User Fee Act will help reduce the time and money spent on developing medicines, allowing companies to get their products into the commercial setting quicker and maximize those therapies' potential.