Header graphic for print
Focus on Regulation

Tag Archives: universities

Hogan Lovells Issues Sponsored Research Alert on Proposed Changes to Federal Policy for Protection of Human Subjects

Hogan Lovells has issued a Sponsored Research Alert outlining a Notice of Proposed Rulemaking (NPRM) issued by the U.S. Department of Health and Human Services (HHS) that seeks to amend the U.S. Government’s policy on protection of human research subjects.  As the Alert describes: The NPRM would substantially change, in several respects, the regulatory framework with which universities and research

D.C. Circuit Issues Landmark Ruling for Stem Cell Therapies

The D.C. Circuit has issued a ruling that will shape the future development of stem cell therapy in the United States.  Through its February 4 decision, the court has broadly upheld FDA’s authority to regulate stem cell therapies as drugs.  Thus, any sense that the development of such therapies may be exempt from the pre-market approval