All eyes on Senate after House passes user fee reauthorization bill

The US House overwhelmingly passed its Food and Drug Administration (FDA) user fee reauthorization bill that has been delayed largely due to the COVID-19 pandemic. Now the ball is with the US Senate, which is expected to hold a postponed markup hearing next week on its version of the bill that includes several different provisions.
Unsurprisingly, the House voted 392-28 to approve the user fee reauthorization on 8 June after it had already been approved unanimously by the House Energy and Commerce (E&C) committee last month.

One area to watch is how the Verifying Accurate Leading-edge IVCT Development (VALID) act is negotiated during conference. The legislation has been an ask from FDA for a long time and is included in the Senate bill and would give the agency additional powers to regulate in vitro diagnostics, including laboratory developed tests, but was not included in the House bill.