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As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
On May 5, 2025, President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of Critical Medicines. The EO directs the U.S. Food and Drug Administration (“FDA”), U.S....more
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while also increasing the...more
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
The Trump Administration issued a notice on Monday titled, “Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients,” which could serve...more
On April 1, 2025, the Secretary of Commerce initiated, pursuant to President Trump’s directive, two new investigations under Section 232 of the Trade Expansion Act of 1962 (Section 232), one on imports of pharmaceuticals and...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
Holland & Knight Health Dose Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more