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nda anda abbreviated new drug clinical trials anda certification clauses anda contents fda drug approval 505(j) anda 505(j) 505 505(b)(2) 505(b)(1) generic drug approval process generic drug approval generic drugs drug approval new drug application foreign studies clinical foreign studies gcp inda investigational new deug clinical studies foreign clinical studies good clinical practices fct fda guidance for industry foreign clinical trials acceptance of foreign fda