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    Enforcement Trends Reveal Record-High Warning Letter Issuances, Common Violations

    The US Food and Drug Administration (FDA) sent more warning letters during 2011 than at any time during the previous 13 years, and FDA official told a San Francisco chapter meeting of the Regulatory Affairs Professionals Society (RAPS). Speaking at a 27 July meeting, Barbara Cassens, director of FDA's San Francisco District office, highlighted recent FDA enforcement trends, including warning letters, injunctions, arrests, convictions, and the most common deficiencies exh...
  • AstraZeneca Sues FDA to Halt Generic Seroquel

    Pharmaceutical manufacturer AstraZeneca filed a lawsuit on 13 March seeking an injunction against the US Food and Drug Administration (FDA) to bar it from allowing generic versions of its blockbuster antipsychotic drug Seroquel to be marketed in the US. FDA denied two Citizen Petitions from AstraZeneca on 9 March that requested FDA delay market entry for any generic products not containing the exact warnings contained on the reference listed drug (RLD). FDA said in its...
  • DOJ Files 'Groundbreaking' Consent Decree Against Ranbaxy, Company Agrees to 'Remedy Deviations'

    The US Department of Justice (DOJ) filed a Consent Decree of Permanent Injunction against Ranbaxy, an Indian generic drug manufacturer, with the US District Court of Maryland on 25 January. The action was taken on behalf of the US Food and Drug Administration (FDA), which had found manufacturing and data integrity deficiencies at numerous Ranbaxy facilities located in India and a US-based Ranbaxy subsidiary's facility in New York. The consent decree requires Ranbaxy to c...