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That category does not require clinical trials and FDA approval like a drug, but rather a 45-minute free online FDA registration without any approval process

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J Med Chem 62:27082719 Whittaker SJ, Demierre M-F, Kim EJ, Rook AH, Lerner A, Duvic M, Scarisbrick J, Reddy S, Robak T et al (2010) Final results from a multicenter, international, pivotal study of romidepsin in refractory cutaneous T-cell lymphoma