On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access…
The FDA is hosting a virtual public workshop on September 19, 2022 on “Increasing the Efficiency of Biosimilar Development Programs.” The workshop will focus on comparative clinical studies and “discuss possible innovative ideas to improve the efficiency of biosimilar development.” The workshop will include detailed discussion on the statistical methods…