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FDA’s ‘Project Facilitate’ Pilot to Collect Metrics on Sponsor Expanded Access Denials

June 3, 2019

FDA aims to harmonize its human subject protection regulations with Common Rule

October 29, 2018

FDA aims to foster gene therapy developments with six new draft guidance documents

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

May 11, 2018

FDA Weighs In on When Pregnant Patients Should be Included in Clinical Trials

April 18, 2018

Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry

February 14, 2018

FDA Issues Draft Guidance on Requirements for Public Warnings for Recalled Products

January 26, 2018

The Crackdown Continues:  FDA Takes Action Against Company And Its Autologous Stem Cell Product, Alleging Significant Safety Concerns

January 5, 2018

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