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- W1517049619 abstract "This chapter contains sections titled: The Controversy 505(b)2 Defined 505(b)2 NDA Submission Checklist FDA 505(b)2 NDA Review Checklist Guidance for Industry1 —Applications Covered by Section 505(b)(2) New DRUGS Sec. 505B. (21 U.S.C. 355C) Research into Pediatric uses for Drugs and Biological Products References Glossary" @default.
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- W1517049619 date "2009-02-27" @default.
- W1517049619 modified "2023-09-27" @default.
- W1517049619 title "505(b)2 New Drug Applications (NDAs)" @default.
- W1517049619 doi "https://doi.org/10.1002/9780470456187.ch6" @default.
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