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
Unburden Yourself: FDA Requests Comments on Ways to Implement President Trump’s Regulatory Reform Executive Orders September 8, 2017
Too Much or Too Little: FDA Requests Comments on New Strategy Regarding Risk Information in DTC Ads August 22, 2017
Short-Fuse Compliance Deadline for Expanded Access Provision in 21st Century Cures Act December 16, 2016
21st Century Cures Offers More Latitude to Promote Health Care Economic Information, but Ambiguities Would Remain December 5, 2016
Let’s Get Real: Meredith Manning Urges FDA to Allow Greater Communication of Real World Data Within Its Current Regulatory Framework November 7, 2016
