The European Medicines Agency requires that drug developers submit a 'pediatric investigational plan' to ensure that there is adequate information about how children fare on experimental medication for many indications before they go to market. But this requirement places an undue constraint on the makers of new hemophilia drugs and threatens to create an unreasonable delay in access to these therapies among adults with this disorder in the EU.
Michael D. Jensen, Donna H. Ryan, Karen A. Donato, Caroline M. Apovian, Jamy D. Ard, Anthony G. Comuzzie, Frank B Hu, Van S. Hubbard, John M. Jakicic, Robert F. Kushner, Catherine M. Loria, Barbara E. Millen, Cathy Nonas, F. Xavier Pi‐Sunyer, June Stevens, Victor J. Stevens, Thomas A. Wadden, Bruce M. Wolfe, Jack A. Yanovski
David W. Miller, Sophie Legras, Andrew Barnes, Mara Cazacu, Oriana Gava, Janne Helin, Katherine N. Irvine, Jochen Kantelhardt, Jan Landert, Laure Latruffe, Andreas Mayer, Andreas Niedermayr, Andrea Povellato, Lena Schaller, Gérald Schwarz, Pete Smith, Francesco Vanni, Lionel Védrine, Davide Viaggi, Audrey Vincent, George Vlahos
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