The FDA’s restructuring of its Office of New Drugs (OND) is well underway with Phase II having kicked off earlier this month and Phase III slated to begin in early December. Wondering how your IND, NDA, or BLA has been affected? See the latest from the FDA here.  Included on the page is a spreadsheet listing affected applications. (Go directly to the Excel file.)

Questions? Concerns?

Reach out to us at The Bracken Group for more on the OND reorg and all things concerning regulatory affairs and the life sciences.