Generics With Poor Bioavailability May Not Use 505(b)(2) "Paper" NDA
This article was originally published in The Tan Sheet
Executive Summary
Generic drug applicants may not use the paper NDA 505(b)(2) mechanism of approval for products that have a reduced rate of absorption compared to the innovator, FDA says in its "Guidance for Industry: Applications Covered by Section 505(b)(2)."