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Cosponsored by CASSS (an international separation science society) and the US Food and Drug Administration (FDA), the January 2010 CMC Strategy Forum explored antibody–drug conjugates (ADCs), which are monoclonal antibodies (MAbs) coupled to cytotoxic...

How Drugs are Developed and Approved The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center’s Office of Testing...

By Dr. Mercola I’ve highlighted the fact that the pharmaceutical industry is responsible for nearly 20 percent of corporate crime in a number of previous articles. Here, I want to draw your attention to an excellent article1,2 on the institutional...

News & Events > How do clinical holds impact drug development programs? How do clinical holds impact drug development programs? Talking with Larissa Lapteva, M.D., Center for Drug Evaluation and Research Before a drug can be tested in people...

PRINCETON, N.J. and LUND, Sweden, April 5, 2016 /PRNewswire/ -- Braeburn Pharmaceuticals and Camurus today announced that the enrollment goals for both the 24-week efficacy study and the 48-week safety study were met on 31 March. These two pivotal Phase...