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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
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
Shortcomings in sterile drug processing landed three companies in trouble with the FDA, while a fourth was chastised for neglect of a customer’s complaint, as reflected in Form 483 inspection reports. 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