FDA Targets Complex Generic Drugs With New Draft Guidance
By Zachary Brennan -
Published 02 October 2017
The US Food and Drug Administration (FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.
Categories: News, US, FDA, Compliance, Generic drugs, Government affairs, Submission and registration
Tags: generic drugs, complex generic drugs, FDA draft guidance
Does FDA Need New Authority to Regulate Complex Generic Drugs?
By Alexander Gaffney, RAC -
Published 01 April 2015
New legislation introduced in the US House of Representatives seeks a government investigation into the US Food and Drug Administration's (FDA) review of complex generic pharmaceuticals to consider whether the agency is in need of new regulatory authority.
Categories: News, US, CDER, Generic drugs
Tags: Bill, Congress, Legislation, Generic Complex Drugs Safety and Effectiveness for Patients Act, Nonbiologic Complex Drugs, Complex Generic Drugs