The 505(b)(2) Drug Approval Pathway

Darrow, JJ; He, MD; Stefaninf, K

Darrow, JJ (reprint author), Brigham & Womens Hosp, Dept Med, Div Pharmacoepidemiol & Pharmacoecon, Program Regulat Therapeut & Law PORTAL, 75 Francis St, Boston, MA 02115 USA.; Darrow, JJ (reprint author), Harvard Med Sch, Boston, MA 02115 USA.; Darrow,

FOOD AND DRUG LAW JOURNAL, 2019; 74 (3): 403

Abstract

Codified in 1984, the Section 505(b)(2) drug approval pathway lies part-way between the regular new drug approval pathway and the generic drug approva......

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