What comes out, must go back in: Court sides with FDA on “same surgical procedure” and “homologous use” definitions governing human cell and tissue products

June 6, 2019

Would you like an extra application with that? FDA mulls requiring dual applications for combination products

February 8, 2019

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

December 27, 2018

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

May 11, 2018

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

May 11, 2018

FDA Shows that it Means Business in Stopping Stem Cell Clinics that Put Patients at Risk

May 11, 2018

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

September 22, 2016

FDA and CMS Make Case Before Congress for FDA Oversight of Laboratory Developed Tests

February 12, 2016

New EMC Guidance Released by FDA

February 9, 2016

Hogan Lovells and Dohmen Life Science Services Medical Device Seminar on New Developments Related to Medical Device Regulation

February 17, 2015