The U.S. FDA’s device center has at times struggled to make the volume of hires under the reigning Medical Device User Fee Agreement (MDUFA), but that wasn’t a problem in fiscal year 2023.

The ongoing controversy over patent subject matter eligibility gained new momentum via a Jan. 23 U.S. Senate hearing, during which a bipartisan pair of senators once again pushed the argument that current jurisprudence for subject matter eligibility is hampering U.S. life science companies.

Legislation passed in the U.S. Congress in 2013 called upon the federal government to dispense with the Federal Helium Reserve by September 2021, a deadline that some stakeholders are grateful to see has passed without action.