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The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From...
On February 6, 2024, the Federal Trade Commission (FTC) issued a comment (the FTC Comment) responding to the National Institute of Standards and…
One day before comments closed on the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, the Department of Health and Human Services (HHS) denied an appeal of a decision not to march in on the blockbuster prostate cancer drug, Xtandi®.
The Biden-Harris Administration recently announced various actions to lower healthcare and prescription drug costs. In one action, the National Institute of Standards and Technology...
The Bayh-Dole Coalition yesterday submitted comments to the National Institute of Standards and Technology (NIST) asking the agency to withdraw the recently published Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights.