Results 1 to 5 of 11

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…

Lynn W. Mehler, Blake E. Wilson

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…

Lynn W. Mehler, Eva Schifini

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…

Heidi Gertner, David Horowitz

“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…

Heidi Gertner, Lynn W. Mehler, Lowell Zeta

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