Phase III Of FDA’s OND Reorganization Pushed Back To Jan. 21

By Beth Wang / January 13, 2020 at 6:08 PM
The third phase of FDA’s Office of New Drugs restructuring has been pushed back from Jan. 13 to Jan. 21, Peter Stein, director of OND, wrote in an email to industry on Monday (Jan. 13). Phase III of the large-scale reorganization will formally establish the Office of Nonprescription Drugs and the Office of Specialty Medicine, as well as the Regulatory Operations Divisions associated with those therapeutic areas. FDA originally anticipated launching phase III on Jan.13, but Stein said minor delays...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.