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GPhA asks FDA to evaluate all changes that made been made to the GDUFA program and eliminate any processes or mandates that arent ...[ Price : $8.95]
FDA says it has already approved Omthera Pharmaceuticals two petition requests seeking NCE exclusivity for its Epanova.[ Price : $8.95]
Four Hogan Lovells attorneys summarize new NIH policies that they say add pressure to the research compliance infrastructure of or...[ Price : $8.95]
FDA says that HeartWare has recalled 105 of its ventricular assist devices manufactured in the last two years due to a design prob...[ Price : $8.95]
Amgen and Allergan file a BLA for ABP 215, a biosimilar copy of Genentechs Avastin (bevacizumab), a recombinant immunoglobulin G1 ...[ Price : $8.95]
Federal Register Notice: FDA announces a 2017 CDER Office of Pharmaceutical Quality Staff Experiential Learning Site Visit Program...[ Price : $8.95]
FDA clears a Xtant Medical Holdings 510(k) for the Irix-C cervical cage for use with autograft or allograft and the expansion of t...[ Price : $8.95]
Regulatory consulting firm Greenleaf Health hires two former senior FDA officials former Office of Regional Operations director D...