[ Price : $8.95]
FDA approves Cook Medicals new 5 mm diameter version of Zilver PTX, the first 5 mm peripheral artery disease drug-eluting stent in...[ Price : $8.95]
FDA releases a draft guidance entitled Good Review Management Principles and Practices for New Drug Applications and Biologics Lic...[ Price : $8.95]
FDA releases a final guidance entitled ANDA Submissions Content and Format that details the information that should be provided i...[ Price : $8.95]
CDER director Janet Woodcock acknowledges that the pendulum has swung away from aggressive FDA drug advertising and promotion enfo...[ Price : $8.95]
Federal Register notice: FDA announces an 11/15 Patient Engagement Advisory Committee meeting to discuss and make recommendations ...[ Price : $8.95]
CDER director Janet Woodcock says her top priorities include modernizing the new drug review program and hiring a permanent direct...[ Price : $8.95]
FDA awards 12 new clinical trial research grants totaling more than $18 million over the next four years to help develop medical p...[ Price : $8.95]
FDA issues a final guidance entitled Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifi...