Category Archives: Risk Management

A Conversation with the FDA About the Nature of REMS

  In 2007, the Food and Drug Administration Amendments Act (FDAAA) was signed into law by President Bush.  The legislation contained a great deal of reform of FDA regulation over the pharmaceutical and biotech industries, one element of which was … Continue reading

Posted in FDA Policy, Risk Management | 2 Comments

FDA Requests Cephalon to Enhance Risk Mitigation Strategies Consistent with Company’s Recommendations

This is not exactly under the headline of news – a Complete Response Letter (CRL) was issued to Cephalon on the 15th of September for its supplemental New Drug Application (sNDA) for FENTORA(R) (fentanyl buccal tablet) [C-II] as a treatment … Continue reading

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Returning a Product to Market After it is Tossed

The FDA announced on Friday that the drug Zelnorm, manufactured by Novartis, would be returning to market for the treatment of women with irritable bowel syndrome (IBS) for certain patients only. "These patients must meet strict criteria and have no … Continue reading

Posted in Drug Safety, Risk Management | 1 Comment

Risky Business

Last week, the FDA announced the formation of a new Risk Communications Advisory Committee that will differ from the existing Drug Safety and Risk Management Advisory Committee, presumably by focusing solely on communication of risk. Yesterday and today, the FDA … Continue reading

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Risk Management Workshop

The FDA is scheduled to announce today a Risk Management Workshop designed to discuss such programs and share information among key stekholders.  Risk Management has been an increasing source of concentration in the post-COX-2 era.  There were compounds prior to … Continue reading

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