Master File Letter Request
US FDA Master File Cross Reference Letter Request
Master Files for CryoStor®, HypoThermosol® FRS, Cell Thawing Media 0.9% NaCl, Cell Thawing Media 5% Dextrose, and BloodStor 27 NaCl, are currently filed with the United States Food and Drug Administration. If you intend to incorporate BioLife Solutions biopreservation media as ancillary or excipient raw materials used in the manufacture, storing, shipping, freezing, and infusion/injection of cell or tissue-based products or therapies and are submitting a filing for a clinical application to the United States FDA, please complete the form below. You may request a cross-reference to our Master Files only if you intend to submit a filing to the United States FDA. This is not for regulatory submissions to regulatory agencies other than US FDA. After verification of your request, we will generate an authorization letter for your files and notify the US FDA of your request.
For support and documentation for using BioLife Solutions’ biopreservation media in clinical applications submitted to regulatory agencies outside the USA, please contact us via our Ask the Scientist page.