Posted by Michael Wonder on 07 Aug 2019
FDA should take additional steps to address factors that may affect approval rates in the first review cycle
7 August 2019 - Companies that make generic drugs—which have the same active ingredients as brand-name drugs—have to apply for FDA approval to market them.
After reviewing an application, FDA may return it with comments. The company can address the comments and resubmit. On average, applications go through 3 of these review cycles before approval (which may take years).
We found FDA approved 12% of generic drug applications in the first cycle in 2015-2017.
