3-Hour Virtual Seminar on FDA's section 804 Drug and 801(d)(1)(B) Biologic Importation Programs

[Adam Fleming]

This presentation outlines the two proposed pathways through which HHS and FDA will allow for the importation of certain drugs originally intended for non-US markets.

Notably, both pathways rely on parties other than the federal government-such as states, wholesalers, pharmacists, and manufacturers-to demonstrate that eligible drugs can be imported into the US safely and with the required cost savings.