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Hebei Yuxing Bio-Engineering, a Chinese producer of active pharmaceutical ingredients, received a warning letter from the FDA citing significant cGMP and data integrity issues discovered at its manufacturing plant. Read More
Better communication with states is needed when the FDA stops a drug compounder from operating, the agency said in a new set of recommendations. Read More
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) are pressing Ariad Pharmaceuticals for answers about why the price of a cancer drug it produces has increased more than $80,000 for a year of treatment. Read More
The International Council for Harmonisation has begun work on two global, multidisciplinary guidelines for drug development: one on waiver policies for bioequivalence studies, and the other on validation of scientific analytical methods. Read More
Industry groups endorsed the FDA’s commitment goals for BsUFA II, saying these proposals would improve review efficiency and ensure adequate staffing, and should be approved by Congress. Read More