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FDA releases a draft guidance to help industry know when a microneedling product is legally considered a medical device subject to...[ Price : $8.95]
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2018.[ Price : $8.95]
Federal Register notice: FDA announces rates for biosimilar user fees for fiscal year 2018.[ Price : $8.95]
FDA grants accelerated approval to Bayer Healthcare Pharmaceuticals Aliqopa (copanlisib) for treating adults with relapsed follicu...[ Price : $8.95]
FDA issues a draft guidance on its current thoughts on how animal transplant models can be used to evaluate organ preservation tec...[ Price : $8.95]
Hyman, Phelps & McNamara attorneys say that since 2015 FDA has been demonstrating flexibility leading to increased fast track appr...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical...[ Price : $8.95]
Medtronic recalls several lots of infusion sets used with all models of Medtronic insulin pumps due to a defective vent membrane.