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Intellectual Property Protection › Medical Devices › Biologics

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

Troutman Pepper Locke on

The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

American Conference Institute (ACI) on

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

Troutman Pepper Locke

Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

Troutman Pepper Locke on

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

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