Fda Approval Calendar 2023

The biosimilar user fee act (bsufa). The fda is committing to a maximum response time of 15 calendar days for acceptability and 70 calendar days (or five before a meeting) for written feedback. Srpt closed friday's trading at $98.24.

The fda submitted its 2023 budget to congress. In august 2017, the fda reauthorization act of 2017 (fdara) was enacted, which renewed the prescription drug user fee program (pdufa) for a sixth time. In fy 2024, the total time to decision goal for fda and industry is 124 calendar days.

Fda approval calendar, pdufa date calendar, ipo calendar and more tools for trading biotech stocks.

Our enhanced fda calendar integrates pdufa dates, clinical trial primary completion dates, and working capital runway estimates into a single timeline that covers all companies facing upcoming pdufa dates. Food and drug administration, and the food safety and. A collaboration between the centers for disease control and prevention (cdc), the u.s. The global market size of duchenne muscular dystrophy drugs is estimated to reach $4.11 billion by 2023, according to a new report by grand view research.