FDA’s Generic Priorities: McClellan Lays Out Ambitious Agenda At GPhA
This article was originally published in The Tan Sheet
Executive Summary
FDA is developing a process to flag NDAs that may pose difficulties for future generic development, Commissioner Mark McClellan, MD/PhD, said at the Generic Pharmaceutical Association annual meeting in Rio Grande, Puerto Rico Jan. 29
You may also be interested in...
FDA Generic Final Rule Requires Polymorph Test Data For Patent Listing
FDA's final rule to reform Hatch/Waxman requires an innovator company to test data to establish that a polymorph claimed in a patent is the same as the active ingredient in the NDA
FDA Generic Final Rule Requires Polymorph Test Data For Patent Listing
FDA's final rule to reform Hatch/Waxman requires an innovator company to test data to establish that a polymorph claimed in a patent is the same as the active ingredient in the NDA
FDA Generic Final Rule Requires Polymorph Test Data For Patent Listing
FDA's final rule to reform Hatch/Waxman requires an innovator company to test data to establish that a polymorph claimed in a patent is the same as the active ingredient in the NDA