Sally Gu
Hogan Lovells
Articles
A change of pace: Accelerated Approval reform passed by U.S. Congress
USA - January 31 2023 The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or…
FDA asks Congress to legislate CBD approval pathway, as new law permits marijuana & CBD research
USA - January 31 2023 In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for…
Modernization of U.S. cosmetics regulation will be phased in over time
USA - January 5 2023 On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics…
“Advancing Real-World Evidence Program” offers drug sponsors early FDA meeting opportunity
USA - November 4 2022 FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that…
World Stem Cell Summit panel cautions over stepped up HCT/P enforcement, reimbursement issues
USA - June 30 2022 Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation last week, Hogan Lovells partners Mike Druckman, Stuart Langbein…
Thomas Beimers, Mike Druckman, James Huang, Stuart M. Langbein, Sarah Thompson Schick
