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Vertice Pharma asked the FDA to revise its draft guidance on bioequivalence requirements for sucralfate oral suspension ANDA to accept in vitro studies for bioequivalence to the reference drug. Read More
The FDA could offset drug price spikes or shortages by allowing reciprocal approvals for certain generic drugs with limited competition, according to joint research from Johns Hopkins, Yale, Harvard and the Council on Foreign Relations, published in BMJ. Read More
The FDA released its justification for the administration’s fiscal year 2019 budget request, detailing how the agency would allocate funds to boost pharmaceutical innovation, combat the opioid crisis and reform over-the-counter drug regulation among other priorities. Read More
FDA Commissioner Scott Gottlieb announced an update of the agency’s framework for using benefit-risk assessments in drug reviews and said he wants to improve the assessments by making increased use of patient perspectives. Read More
The FDA approved Teva’s generic in 2004 as a conditional “carve-out” approval, with GSK retaining exclusive rights to market the drug for chronic heart failure. Read More
A Delaware judge threw out a 2017 decision that had Teva on the hook for more than $235 million over its generic for GlaxoSmithKline’s chronic heart failure and blood pressure drug Coreg (carvedilol). Read More
The Government Accountability Office reviewed the FDA’s relabeling of Mifeprex — an early abortion pill covered by a risk evaluation and mitigation strategy — and concluded that the agency’s monitoring did not raise significant safety concerns. Read More