Examine FDA’s enforcement tools and procedures and the factors FDA weighs when making enforcement decisions. Review of prohibited acts of adulteration and misbranding. Discuss international harmonization and import and export regulations.
Beth P. Weinman, Counsel, Ropes & Gray LLP
Joshua Oyster, Associate, Ropes & Gray LLP
This session was recorded as part of FDLI's Virtual Introduction to Biologics and Biosimilars Laws and Regulations Course in March/April 2020.