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FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

June 24, 2019
https-www-hlregulation-com-files-2019-06-pharma-biotech_cells-jpg

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

FDA and DoD strengthen collaboration for medical products with military applications that could also be expanded to the general population

November 8, 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FDA aims to foster gene therapy developments with six new draft guidance documents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

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

January 5, 2018

New Legislation Increases Access to Medical Products for Military Applications

December 12, 2017

FDA Clarifies and Expands Eligibility for RMAT Designation for Gene Therapies

November 22, 2017

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Mike Druckman

Connect: http://www.hoganlovells.com/mike-druckman/Email
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