Even though the executive order that requires regulatory offsets may only have limited application to the agency, industry experts warn that it still could prove to be unwieldly to implement.

For the most part, industry experts and lobbyists say they still have questions about President Trump's latest executive order, which requires agencies to rescind two regulations for every one rule that is implemented. With key leadership positions at HHS and FDA still unfilled, some say they are taking a wait-and-see approach before concluding how the order will be interpreted.

First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.