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The FDA this year aims to answer key questions on which quality metrics it will collect from drugmakers, how to develop biosimilars and how to use social media to promote products. Read More
Washington state oncology drug developer OncoGenex is taking back rights to the experimental cancer therapy custirsen, ending a five-year collaboration with Israeli manufacturer Teva Pharmaceuticals. Read More
In a closely watched case, a federal judge has denied Celgene’s motion to dismiss a lawsuit alleging the brandmaker engaged in anticompetitive conduct by refusing to turn over product samples for ANDA bioequivalence testing. Read More
With the FDA stepping up scrutiny of data integrity during facility inspections, drugmakers must be ready to answer tough questions about their electronic record system, an inspections expert said. Read More
A compounding pharmacy pled guilty recently to manufacturing contaminated products that caused skin infections, the first compounder to be convicted of criminal charges for poor quality since the FDA gained new authority in 2013. Read More