6/30/2025 3:07:58 PM FDA Scrutinizes Clinical Trials Exporting U.S. Genetic Material By Kate Hardey Brandon von Kriegelstein On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American...
6/30/2025 2:25:43 PM DORA Delegated Regulation on Threat-Led Penetration Testing Published in Official Journal By Nathaniel Lalone Ciara McBrien The Delegated Regulation, which contains regulatory technical standards (RTS) on threat-led penetration testing (TLPT) requirements under...
6/27/2025 1:07:18 PM FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers By Kate Hardey Brandon von Kriegelstein On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the...
6/26/2025 8:55:55 PM Texas Federal Court Vacates Most of 2024 HIPAA Rule on Reproductive Health Information By Lisa Prather Brandon von Kriegelstein In 2024, the U.S. Department of Health and Human Services’ (“HHS”) implemented a new privacy rule under the Health Insurance Portability...
6/25/2025 1:24:06 PM 5 Things to Know About Senate Bill 1318: Navigating New Non-Compete Restrictions for Healthcare Practitioners in Texas By Kenya Scott Woodruff Ramana Rameswaran Michelle Apodaca Lisa Prather Taylor Stilwell +2 more... Show less On June 20, 2025, Texas Governor Greg Abbott signed into law Senate Bill 1318 (“SB 1318”), which amends Texas Business & Commerce Code...
6/24/2025 9:24:18 PM UK Data Use and Access Act Now in Force By Trisha Sircar On June 19, 2025, the UK Data Use and Access Bill (DUA Bill) finally received Royal Assent and passed into law as the Data Use and Access...
6/24/2025 3:27:15 PM SCOTUS Holds That Courts Are Not Bound by FCC Orders Interpreting the TCPA By Ted Huffman On June 20, 2025, the U.S. Supreme Court delivered an opinion that could dramatically change the landscape of class actions under the...
6/20/2025 2:57:52 PM Senate Passes GENIUS Act: Landmark Federal Stablecoin Bill Advances to House By Dan Davis Christina Grigorian Alex Kim The US Senate has passed the Guiding and Establishing National Innovation for U.S. Stablecoins Act (GENIUS Act) by a vote of 68-30, a...
6/16/2025 4:36:07 PM FDA Reimagined: Faster, Friendlier, and Focused on Cures By Kate Hardey Brandon von Kriegelstein On June 10, 2025, the Commissioner of the FDA, Dr. Martin Makary, and Dr. Vinayak Prasad, the Director of the FDA’s Center for Biologics...
6/16/2025 3:01:26 PM FCA Consults on Proposals for Stablecoin Issuance and Cryptoasset Custody By Carolyn Jackson Nathaniel Lalone Neil Robson Christopher Collins Ciara McBrien Sara Portillo +3 more... Show less The UK Financial Conduct Authority (the FCA) recently published two consultations: CP25/14 on stablecoin issuance and cryptoasset custody...
6/16/2025 1:17:09 PM SEC Requests Stay of CAT-Related Class Action Proceedings By James Brady Michael Lohnes Nicholas Gervasi On June 11, the Securities and Exchange Commission (SEC) requested a stay of proceedings in a pending class action lawsuit challenging...
6/13/2025 7:46:07 PM Updated FCPA Guidance By Johnjerica Hodge Shortly after taking office President Trump signed an executive order titled, “Pausing Foreign Corrupt Practices Act Enforcement to...
6/13/2025 7:32:58 PM FTC and DOJ Announce Listening Sessions on Lowering American’s Drug Prices By Kate Hardey Lance Soderstrom Deepro Mukerjee Taylor Stilwell +1 more... Show less On April 15, 2025, President Donald Trump issued Executive Order No. 14273, “Lowering Drug Prices by Once Again Putting Americans First,...
6/12/2025 7:52:42 PM Takeaways from the 2025 NYU International Hospitality Investment Forum (IHIF) By Henry Stapp Frank Arado Last week in New York, hospitality and lodging industry leaders convened at the 2025 NYU International Hospitality Investment Forum...
6/12/2025 3:32:22 PM On the Hot Seat: Brian Quintenz Faces Senate Spotlight in CFTC Confirmation Hearing By Carl Kennedy Dan Davis Matt Kluchenek Alex Kim Nicholas Gervasi +2 more... Show less Brian Quintenz appeared before the Senate Committee on Agriculture, Nutrition, & Forestry (Senate Ag Committee) for his June 10th...
6/11/2025 8:51:39 PM SEC Form PF Amendments Delayed Again By Adam Bolter Today, the Securities and Exchange Commission (SEC) voted to extend the compliance date for rule amendments that expand the reporting...