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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 12/9 to discuss a Teva Pharmaceutical BLA to im...[ Price : $8.95]
Federal Register Notice: FDA requests nominations for members to serve on the CDRH Patient Engagement Advisory Committee.[ Price : $8.95]
Inrange Systems petitions FDA asking that it detain a competitors product because it is allegedly not cleared or approved for sale...[ Price : $8.95]
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FDA revises a draft guidance on how to demonstrate the bioequivalence of generic versions of Boehringer Ingelheim Pharmaceuticals ...[ Price : $8.95]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...