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| препараты, отвечающие требованиям 361 раздела Закона о службе общественного здравоохранения (HCT/Ps that meet criteria identified in 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act do not require premarket approval by FDA (i.e., BLA or PMA) and only need to comply with GTP regulations. Wakeful dormouse) | |||