Search Results for generic drug review

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FDA Expands Generic Drug Priority Reviews By Zachary Brennan - Published 09 November 2017

Talk of bringing down the price of pharmaceuticals often hinges on generic competition, and the US is seeing approvals of new generic drugs faster and more consistently than ever – a trend likely to continue.

Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug review, generic drug approval, GDUFA

Generic Drug Review Dashboard: FDA Offers a First Look By Zachary Brennan - Published 10 February 2016

As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs).

Categories: News, US, FDA, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: generic drug review, ANDA backlog, FDA and ANDAs, generic drug applications