Derrick Gingery, Senior Writer, Pink Sheet
The US FDA's prescription drug, generic drug, and biosimilar user fee programs are expected to generate nearly $1.8bn in revenue in FY 2022 to help pay for marketing application reviews, manufacturing facility inspections, and policy development.
We have been closely reporting on the program renewal process, which takes place every five years, and is where industry and FDA representatives determine fee calculations, update application review timelines, and outline other policy changes with wide-ranging impact on developing and marketing drugs in the US.
The agreement will then be turned into legislation that Congress will use to make additional changes at the agency.