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Federal Register Notice: FDA reveals high priority recommendations from an independent assessment of the device review process.[ Price : $8.95]
Nuvilex plans a late-phase clinical trial comparing its investigational treatment with gemcitabine in patients with advanced, inop...[ Price : $8.95]
CDER director Janet Woodcock says FDA inspectors have shifted more focus to drug manufacturers that have operations that are antiq...[ Price : $8.95]
FDA counselor to the commissioner and Global Regulatory Operations and Policy (GO) acting deputy commissioner John M. Taylor resig...[ Price : $8.95]
Attorneys general from 29 states ask FDA to reconsider its approval of Zogenix Zohydro ER or order it to be reformulated to be abu...[ Price : $8.95]
Consultants Booz Allen Hamilton recommend four steps FDA could take to improve the medical device submission review process under ...[ Price : $8.95]
Additionally, FDA says it will expedite export certificate requests and prioritize device and pre-amendment determination requests...[ Price : $8.95]
FDAs Allergenic Products Advisory Committee votes 9 to 1 that available data support approval of a BLA for Oralair, indicated for ...