US Federal Courts Can Operate Until Jan. 25; Patent Office Faces Eminent Closure Under Shutdown
Federal courts and USPTO will soon run out of funds that have allowed them to continue normal operations; pending ANDAs to get same filing date, which could lead to FDA legal challenges.
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US FDA draft guidance says substantive changes to reference product may require major ANDA amendment and 10-month review goal for the generic.
More than 300 generic drug applications might be officially filed when the shutdown ends, substantially increasing stress on assessors and other Office of Generic Drugs staff.
Compounding carryover money runs out, crippling some activities although inspections will continue; countdown to the end of PDUFA fee balance continues.