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As federal right-to-try legislation gathers steam on Capitol Hill, the FDA rolled out measures to streamline its expanded access process — including loosening institutional review board requirements — and issued new guidance to manufacturers on its use of adverse event data. Read More
Drug sponsors should ask themselves three data integrity questions before the FDA can, according to John Avellanet, managing director and principal consultant at Cerulean Associates, during an expert panel at the RAPS’ 2017 Regulatory Convergence meeting. Read More
The FDA updated several ICH guidance documents to reflect Canada’s adoption of interchangeable chapters from the U.S., European and Japanese pharmacopeias. Read More
CDER’s Office of Manufacturing Quality issued 45 warning letters through Sept. 1 of this year, not counting actions against compounders, according to Francis Godwin, a division director in OMQ. Read More
Drug companies can move beyond simply satisfying FDA regulations by meticulously tracking quality elements, Baxter International quality expert Kevin Cloonan said Monday at the PDA/FDA Joint Regulatory Conference in Washington, D.C. Read More
A health plan for a carpenters’ union filed a class action lawsuit against Celgene, claiming the drugmaker engaged in anti-competitive practices to maintain its monopoly on Thalomid and Revlimid. Read More
As part of a broad effort to increase competition and lower drug prices, the FDA spelled out what it expects from sponsors of abbreviated new generic drug applications who are seeking early meetings to smooth the approval review process. Read More