Insights

New York – August 19, 2025: Crowell & Moring represented Halda Therapeutics in a strategic research collaboration, worth over $1 billion in total potential value, with VantAI to discover next-generation RIPTAC (Regulated Induced Proximity Targeting Chimeras) medicines.

On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.

On December 16, 2025, the European Commission published its proposal for a regulation establishing a European Biotech Act to strengthen the EU's biotechnology and biomanufacturing sectors with a primary focus on health.

The European Commission has proposed targeted amendments to the Medical Devices Regulation 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR). The amendments are intended to simplify the rules, reduce the administrative burden, and enhance the predictability and cost-efficiency of notified body certification, while maintaining high public health and patient safety standards.

The landscape of AI governance and regulation is shifting. Following the release of the White House’s “America’s AI Action Plan” in July 2025 and the President’s signing of related Executive Orders, the White House has emphasized (at least rhetorically) a preference for innovation, adoption, and deregulation. But that does not tell the entire story. The Administration remains committed to exercising a heavy hand in AI, including by banning the U.S. government’s procurement of so-called “woke AI,” intervening in the development of data centers and the export of the AI technology stack, imposing an export fee for certain semiconductors to China, and assuming a stake in a U.S. semiconductor company. State legislatures are also racing to implement their own regulations, particularly around AI’s use in critical areas, such as healthcare, labor and employment, and data privacy. The many sources of regulation raise the specter of a fragmented compliance environment for businesses. This webinar will delve into the Administration’s AI strategy, going beyond the headlines to analyze:

On October 16, 2025, Partner Matthew F. Ferraro, Partner and CHS Managing Director Jason Johnson, and Counsels Jacob Canter and Anna Z. Saber hosted a webinar on the shifting dimensions of AI governance and regulation. They discussed federal policy, state laws, international efforts, and key court cases and how these many sources of regulation serve to fragment the AI compliance environment for businesses and how firms can respond. Click here to view the webinar on demand.