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A Texas judge ruled state legislators are entitled to see details of Pfizer’s Medicaid pricing practices, denying a legal challenge by the drugmaker. Read More
Republicans and Democrats on the House Oversight Committee pressed Allergan for an explanation of its decision to transfer patents for its lucrative dry-eye drug Restasis to a Mohawk tribe to protect them from challenges by would-be generic competitors. Read More
HHS has once again pushed back the effective date of its final rule that would institute fines for drugmakers who overcharge for products covered by a hospital discount program. Read More
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