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Starting early next year, manufacturers will learn faster whether their drug applications have serious quality deficiencies under a sweeping reorganization of CDER’s quality functions into a new “super office.” Read More
Drugmakers should upgrade their quality assurance systems to quickly identify and fix any manufacturing problems that could spiral into a shortage, according to a wide-ranging plan to address shortfalls in drug supplies. Read More
Regulators in Brazil have unveiled the country’s first drug-tracking platform, a key piece of infrastructure that will connect Anvisa and drug registration holders as they implement the country’s 2013 National Drug Control System. Read More
Joining pharma’s global transparency movement, members of a pharmaceutical association in Greece have committed to disclosing details of their financial interactions with healthcare professionals and organizations. But a loophole in such voluntary industry codes could diminish the impact of the reporting, critics say. Read More
UK’s healthcare cost watchdog has recommended against coverage of Celegene’s multiple myeloma drug Imnovid, in combination with dexamethasone, for treating MM patients who have failed on at least two previous treatments and whose disease has progressed on the last therapy. Read More
The FDA should make its consideration of ANDA first-filer status a far more public process, say generics firms that continue to seek more transparency and communications from the agency in general on the generic drug application process. Read More
The U.S. Trade Representative’s Office has launched a review of India’s intellectual property regime that will focus in large part on pharmaceutical IP issues, including the country’s policy of providing access to affordable medicines. Read More
The FDA wants to understand how patient perceptions of medications change when pharmacies switch from brand to generic products or between the same generics made by different manufacturers. Read More
The FDA did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations. Read More
Takeda has asked a federal court to rescind the FDA’s approval last month of Hikma Pharmaceutical’s gout treatment Mitigare, claiming that the agency improperly cleared the rival company’s drug application without referencing Takeda’s own gout therapy Colcrys or its safety warnings. Read More