As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and document backlogs to operational restructuring. While core review functions are still running, early...more
The Food and Drug Administration’s Center for Tobacco Products (“CTP”) will hold a two-day public meeting on the agency’s premarket tobacco product application (“PMTA”) process. The meeting will be held October 23-24 and can...more
The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more