Unless a drugmaker has an upcoming PDUFA date or a meeting scheduled with the FDA, chances are the impact would be minimal – provided the shutdown is only short term.
The last shutdown of nonessential government programs lasted more than three weeks, from Dec. 16, 1995, to Jan. 6, 1996.
By law, the FDA may continue activities funded by user fees and carryover money. The Patent and Trademark Office, for example, said it has sufficient prior year reserve fee collections to operate for about four weeks.
Given the vital role federal agencies play in drug R&D, the full impact of the shutdown on biopharma remains to be seen. Read the full bioworld.com story here.
