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In response to comments, we stated in section 40.1.2 of the revised Medicare Part D Drug Inflation Rebate Guidance that Part D rebatable drugs first approved or licensed on or before October 1, 2021, that were not marketed until after that date and thus did not have AMP in the statutorily defined payment amount benchmark period (that is, January 1, 2021, through September 30, 2021) would be treated in the same manner as subsequently approved drugs for purposes of establishing the payment amount benchmark period, benchmark period CPI-U, first applicable period, and first applicable period CPI-U

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A shared framework for the common mental disorders and non-communicable disease: key considerations for disease prevention and control

Others remain unapproved but legal to possess for research

Abildgaard C, do Canto LM, Rainho CA, Marchi FA, Calanca N, Waldstrm M, et al

Payne CK, Terai A and Komatsu K: Research criteria versus clinical criteria for interstitial cystitis