FDA's CDER withdrawing old draft guidances

FDA's Center for Drug Evaluation and Research (CDER) is withdrawing 23 draft guidances published before 2010 that the center said are out of date. The list includes guidances covering cGMP compliance for manufacturing; the development of antimicrobial drugs; approval of ANDAs and 505(b)(2) applications under the Hatch-Waxman Act; and qualifying for pediatric exclusivity under the Best Pharmaceuticals for Children Act, which was made permanent last year by the Food and Drug Administration Safety and Innovation Act. ...