~~~FDA IND # STILL Unverified!! Read Below!!
Thank you for your recent inquiry to the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) regarding HemaXellerate. Your inquiry has been forwarded to FDA's Center for Biologics Evaluation and Research for reply. CBER, one of seven centers within FDA, is responsible for the regulation of many biologically-derived products, including blood intended for transfusion, blood components and derivatives, vaccines, allergenic extracts, and cell, tissue and gene therapy products.
Unfortunately, we will be unable to provide you with the information you are seeking. Federal regulations (21 CFR 601.50 and 21 CFR 601.51) prohibit FDA from disclosing, or even acknowledging any information regarding unapproved products. You may contact the sponsor or manufacturer directly regarding information about their product.
We hope this information is helpful.
Sincerely,
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As always,, the above Post is "Just My Opinion!" ;-)