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FDA commissioner Margaret Hamburg tells an industry meeting why more effective, faster and more visible FDA enforcement will be go...[ Price : $8.95]
Emphasis on regulatory compliance is cited at an industry conference as being among the most important changes brought to FDA by c...[ Price : $8.95]
FDA tells manufacturers of promethazine to add a Boxed Warning to the drugs labeling to highlight the risk of severe tissue damage...[ Price : $8.95]
A lawyer representing industry interests tells a regulatory affairs meeting that FDA rulemaking and guidance development is in urg...[ Price : $8.95]
FDA approves Sirion Therapeutics NDA for Zirgan 0.15% for treating herpetic keratitis.[ Price : $8.95]
DDMAC says that Web pages and a display timeline for Allergans Latisse omit and minimize significant risk information.[ Price : $8.95]
FDA gives Keryx perifosine orphan drug designation for treating multiple myeloma.[ Price : $8.95]
The New York Times looks at the controversy surrounding FDAer Richard Pazdur, who is criticized for being either too quick or too ...