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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
An FDA advisory committee voted to recommend approving a formulation of desmopressin for frequent nighttime urination, with some saying it should be approved in a separate indication that had not been explicitly tested in a clinical trial. Read More
Sandoz is asking the FDA not to approve generic versions of GlaxoSmithKline’s Advair Diskus, unless the copycat versions have undergone adequately controlled pharmacokinetic studies. Read More
The National Academy for State Health Policy is proposing 10 measures to reduce drug spending, which include greater transparency on pricing and better enforcement of antitrust laws. Read More