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President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more
On April 29, 2024, the U.S. Department of Commerce officially published a final rule in the Federal Register that formally incorporates a medical device license exception into the Export Administration Regulations (“EAR”) for...more
Congress — Big Agenda & Little Time - With the holidays behind us, Congress returned this week for the second half of the 118th Congress with a long list of items to address and, as the 2024 campaign season ramps up, limited...more
The Department of Commerce and the National Institute of Standards and Technology are requesting comments on a “draft guidance framework designed to help federal agencies evaluate when it may be appropriate to exercise...more
On December 7, 2023, the Biden Administration announced several new initiatives intended to “promote competition” in the health care sector. These initiatives reflect a broad range of concerns about rising costs in health...more
Senate Finance Committee Examines Drug Shortages. The hearing addressed concerns and explored potential solutions related to drug shortages in the United States, particularly focusing on essential medications. The hearing...more
On October 30, 2023, the Biden-Harris Administration unveiled a sweeping Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI). The Executive Order represents the most...more
On October 30, 2023, the White House released an Executive Order for Safe, Secure, and Trustworthy Artificial Intelligence (EO), which outlines a sweeping plan for encouraging the development and managing the risks of...more