Search Results for complex generic drugs

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FDA Targets Complex Generic Drugs With New Draft Guidance By Zachary Brennan - Published 02 October 2017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(FDA) on Monday kicked off a two-day meeting on modernizing generic drug development and released two new draft guidance documents on complex generic drugs – an area where increasing competition can be difficult.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Tags: generic drugs, complex generic drugs, FDA draft guidance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