FDA Knows Its Own Strength—and It Includes Concentration
FDA Law Blog: Biosimilars
FEBRUARY 26, 2024
This of course, make sense—after decades of experience implementing the Hatch-Waxman, Congress and FDA had learned a few new tricks by 2009/2010. To Boehringer’s first and most significant argument, that Congress intended the terms “strength” to match FDA’s interpretation in 2009—prior to the codification of the definition in 21 C.F.R.
Let's personalize your content