To view a copy of this licence, visit About this article Cite this article Barrea, L., Annunziata, G., Verde, L
According to FDA guidance: The limitations in section 503A(b)(1)(D) apply to the compounding of drug products that are essentially copies of a commercially available drug productnot only to drugs that are exact copies or even to drugs that are nearly identical
For an allogeneic (off-the-shelf) CAR-T product derived from donor cells, comparability testing against a reference product is at least conceptually possible
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Researchers should try to contact the company before making a purchase
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