[ Price : $8.95]
FDA releases a guidance on Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments, a revi...[ Price : $8.95]
Microbiology Devices Panel members recommend down-classification of cytomegalovirus viral load devices from Class 3 to Class 2.[ Price : $8.95]
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...