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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
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 FDA is proposing annual dues for sponsors of one or more approved ANDAs to guarantee a more predictable stream of funding that will raise revenues for the agency’s generics program starting in fiscal 2018. Read More
The FDA intends to review 90 percent of priority review ANDAs deemed complete within 8 months, according to the agency’s GDUFA II commitment letter. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use is recommending the approval of five new medicines and three generics to treat a range of illnesses from cancer to HIV. Read More