Recent Scholarship: FDA and Other Regulators

As readers know, FDA does not operate in a vaccuum; it has relationships with, and sometimes collaborates with, other federal regulators. It shares information with them, it may receive information from them, and sometimes it shares jurisdiction with another agency or shares responsibility for implementing a particular program. (For instance, both PTO and FDA play a role in implementing the patent term restoration provisions of section 156 of the Patent Act. Some of my work explores the FDA/PTO intersection.) Today I highlight two recent pieces of scholarship focusing on FDA and other regulators. Both, I think, reflect the same notion; as Professor Tammi Etheridge (who writes the second article) says, this work “belies the notion that all agency collaboration is good collaboration.” 

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