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Regenxbio is challenging in federal court the FDA’s recent decision to place holds on the company’s two trials for retinal disease therapies, saying the agency did not follow its own regulations in handling the matter. Read More
Public Citizen has petitioned the FDA and the Drug Enforcement Administration to reclassify tramadol as a Schedule II controlled substance because of its high potential for abuse. Read More
The agency is encouraging applications that qualify for accelerated approval through its fast-track, breakthrough therapy and priority review pathways. Read More
The agency can collect backlog fees from holders of ANDAs that were pending on Oct. 1, 2012 and did not receive a tentative approval prior to that date. Read More
A New York judge has set a Jan. 20 trial date for opioid litigation led by the state’s attorney general against opioid manufacturers and distributors. Read More