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Hamburg on Why FDA Enforcement is Good for You

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FDA commissioner Margaret Hamburg tells an industry meeting why more effective, faster and more visible FDA enforcement will be go...

Regulatory Compliance a Top Obama Change at FDA

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Emphasis on regulatory compliance is cited at an industry conference as being among the most important changes brought to FDA by c...

FDA Orders Injectable Promethazine Boxed Warning for Tissue Injury

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FDA tells manufacturers of promethazine to add a Boxed Warning to the drugs labeling to highlight the risk of severe tissue damage...

More Transparency Needed During Rulemaking: Lawyer

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A lawyer representing industry interests tells a regulatory affairs meeting that FDA rulemaking and guidance development is in urg...

FDA OKs Sirions Zirgan for Ocular Disease

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FDA approves Sirion Therapeutics NDA for Zirgan 0.15% for treating herpetic keratitis.

Latisse Web Pages Omit and Minimize Risks: DDMAC

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DDMAC says that Web pages and a display timeline for Allergans Latisse omit and minimize significant risk information.

FDA Gives Orphan Designation to Keryx Myeloma Drug

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FDA gives Keryx perifosine orphan drug designation for treating multiple myeloma.

Does FDAs Richard Pazdur Help or Hurt Cancer Research?

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The New York Times looks at the controversy surrounding FDAer Richard Pazdur, who is criticized for being either too quick or too ...

Lifepak CR Recall is Class 1

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CDRH says Physio-Controls recall of Lifepak CR Plus AED units is Class 1.

FDA Denies Subutex, Suboxone Ingredient Petition

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FDA says it wont order applicants for generic forms of Subutex and Suboxone to use only inactive ingredients meeting requirements ...