chapter  13
25 Pages

Chemistry, Manufacturing, and Control (ICH Quality Guidelines)

WithJohn R. Rapoza, Evan B. Siegel

INTRODUCTION With the enactment of the FDAModernization Act of 1997, Food and Drug Administration Amendments Act 2007, and reauthorization of the Prescription Drug User Fee Act of 2007, the drug approval process by FDA is expected to be streamlined further. The agency is aggressively generating guidance documents to implement the provisions of the statute, so it is up to the drug sponsor to prepare drug submissions that are complete and in a format that will facilitate the review for a rapid approval.