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Drugmakers have asked the FDA to think “globally” with the international community as they weighed in on the agency’s draft guidance on established conditions for reporting chemical, manufacturing and control changes. Read More
Ohio Secretary of State John Husted is facing a lawsuit for failing to transmit the proposed Ohio Drug Price Relief Act citizen petition to the state’s General Assembly, as required by the state’s constitution. Read More
Physician groups frustrated with federal plans to pair different biosimilar drugs together for billing and reimbursement purposes are turning to Congress for help. Read More
The House Energy & Commerce Committee is calling on the GAO to evaluate whether the FDA’s regulatory pathway for generic versions of complex drugs is sufficient. Read More
The director of FDA’s CDER has laid out new priorities for the center to focus on in 2016, with negotiations for GDUFA and improvements at the Office of Generic Drugs among the center’s “front burner” priorities. Read More
The FDA’s first public meeting on the 2017 reauthorization of the Biosimilars User Fee Act brought calls for increased transparency in terms of how the agency regulates biosimilars and a rethinking of how these products will be named. Read More
Eleven healthcare groups are asking a Senate committee to examine alleged industry abuse of REMS safeguards as a possible cause of rising drug prices. Read More
A journal article asking the FDA to defy its own policies concerning mass compounding and drug importation to combat rising drug prices comes from an unusual source: the agency’s former second-in-command. Read More
The U.S. Department of Justice has filed an injunction to halt Dallas, Texas-based Downing Labs from manufacturing and distributing drugs until the compounder brings its operations into compliance with FDA regulations. Read More
A federal appeals court has ruled that Caraco Pharmaceutical Laboratories’ assumption that its plants wouldn’t be closed for GMP violations was not legal justification for it to skirt layoff-notice labor laws. Read More