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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
Most independent, chain and hospital pharmacies are implementing requirements for drug tracing but many are not properly reviewing the data, according to a new report from the HHS Office of Inspector General. Read More
In comments on the FDA’s draft guidance on drug and biologics labeling, Amgen urged the agency to follow a precedent set by a previous agency opinion that a USP monograph title consisting of a core name without a suffix does not apply to biologics whose nonproprietary names include a suffix. Read More