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The FDA strongly supports transitioning the opioid painkiller market toward abuse-deterrent formulations, Commissioner Scott Gottlieb told a Senate committee examining the abuse epidemic. Read More
The American Civil Liberties Union has sued the FDA over restrictions on access to abortion-causing drugs, saying the restrictions are not grounded in science. Read More
Gilead asked the Ninth Circuit Court of Appeals to put its ruling reviving a whistleblower suit against the drugmaker on hold while the company petitions the United States Supreme Court to hear the case. Read More
The FDA replaced its 2001 guidance on organizing electronic common technical documents for submission, updating its recommendations to industry with the ICH’s M4 guideline. Read More
Following the launch of GDUFA II Oct. 1, the FDA released final guidances and timelines for reviewing generic prior approval supplements and API drug master files. Read More
Soliris is a breakthrough therapy for the treatment of the rare and life-threatening conditions paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Read More