On Demand Webinar: Recent Revisions to the ANDA Prioritization MAPP – Jan. 2020

The FDA offers priority review to abbreviated new drug applications (ANDAs) that may have meaningful impact on generic drug access. Priority review means that FDA gives an ANDA submission either (1) a shorter goal date, or (2) an expedited review. For an ANDA submission to be eligible for priority r
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news