Standards & Regulation

Jul 28, 2016
By Pharmaceutical Technology Editors
NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.
Jul 27, 2016
FDA and industry seek speedy Congressional approval of new user fee plan.
Jul 26, 2016
The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.
Jul 22, 2016
By Pharmaceutical Technology Editors
The company manufactures biological drug products and intermediates for the allergy vaccine market.
Jul 22, 2016
By Pharmaceutical Technology Editors
The agency has recommended granting marketing authorization in the EU for Truvada.
Jul 22, 2016
By Pharmaceutical Technology Editors
The agency recommends suspending drugs developed with bioequivalence studies performed at Semler Research Centre Private Ltd, Bangalore, India.
Jul 22, 2016
By Pharmaceutical Technology Editors
The agency will review Mylan and Biocon’s biosimilar to pegfilgrastim.
Jul 21, 2016
Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.
Jul 21, 2016
By Pharmaceutical Technology Editors
GenPak Solutions is cited by FDA for cGMP violations at its Hilliard, Ohio facility.
Jul 20, 2016
The committee voted unanimously in favor of approving the drug, but the majority supported implementing additional risk management.
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