Podcast: Non-binding Guidance: Breakthrough Devices Program
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
Last week, the World Health Organization (WHO) announced that it signed a memorandum of understanding with the International Generic and Biosimilar Medicines Association (IGBA) to promote access to generics and biosimilars. ...more