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FDA says it is changing longstanding practice of not publically posting public docket comments from individual consumers on the go...[ Price : $8.95]
FDA accepts for review a Heron Therapeutics NDA resubmission for Sustol (granisetron) injection extended release, indicated for pr...[ Price : $8.95]
FDA revises a draft guidance on how to demonstrate the bioequivalence of generic versions of Boehringer Ingelheim Pharmaceuticals ...[ Price : $8.95]
CDER director Janet Woodcock tells a Senate hearing that the Center is planning to release three biosimilar-related guidances in t...[ Price : $8.95]
Recognizing the importance of patient input on regulatory issues, FDA establishes a Patient Engagement Advisory Committee, which w...[ Price : $8.95]
SynCardia Systems begins a Class 1 recall of its Freedom Driver System because a part may fail causing the device to stop working.[ Price : $8.95]
FDA grants a qualified infectious disease product designation to Cempra, Inc. for its investigational antibiotic Taksta for treati...[ Price : $8.95]
Federal Register Notice: FDA plans to post comments submitted by individuals on the regulations.gov Web site.