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A congressman wants answers on why a pharmaceutical company has increased the price of a medication used to treat lead poisoning in Flint, Mich., the latest in a string of challenges by legislators to drug company pricing. Read More
The European Medicines Agency has begun publishing clinical study data for all new drug applications submitted after Jan. 1, 2015, regardless of approval status. Read More
Draft guidance on companion diagnostics development needs more clarity on what products it covers and greater detail on clinical trial criteria, trade groups said in comments on the draft. Read More
Industry groups have backed the FDA’s commitment goals for GDUFA II, bringing the user fee program closer to reauthorization after Friday’s public meeting. 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
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
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