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  • UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment'

    • 26 June 2012
    Sometimes it takes just a single powerful argument to derail an intended final rule. The US Food and Drug Administration (FDA) announced on 27 June its withdrawal of a final rule as the result of a "significant adverse comment." The agency did not elaborate on the comment or its significance, but the intended final rule was published on 23 March 2012. Entitled, "Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agen...
  • FDA Appeals Antibiotic Decision, Earning Congresswoman's Ire

    The US Food and Drug Administration (FDA) quietly moved to appeal a ruling by US Magistrate Judge Theodore Katz, who said the agency must either plan to withdraw its approval for most antibiotics used in animal feed or withdraw approval for their non-therapeutic applications. The agency, in conjunction with the US Department of Health and Human Services, filed an appeal with the US Second Circuit Court of Appeals in New York on 21 May. The case was originally filed by ...
  • Judge Orders FDA To Remove Antibiotics from Animal Feed

    A federal judge ruled this week that The US Food and Drug Administration (FDA) must either make plans to withdraw approval for the use of most antibiotics in animal feed or withdraw approval for non-therapeutic use of those antibiotics, reports Reuters . The 22 March ruling by US Magistrate Judge Theodore Katz comes after mounting concerns about antibiotic resistance and emerging so-called "superbugs" being seen as a threat to human health. Katz noted FDA had recently ...
  • Shire Pulls BLA Submission After FDA Demands More Clinical Trials

    • 16 March 2012
    Biopharmaceutical manufacturer Shire withdrew its Biologics License Application (BLA) for Fabry drug Replagal (agalsidase alfa) after the US Food and Drug Administration (FDA) indicated that the company needed to conduct more clinical trials. Ireland-based Shire's withdrawal of its application on 15 March was reportedly due to the perception that FDA's demands would create a "significant delay" that would push back any possible approval of the product by years. FDA has ...
  • EMA Calls for Withdrawal of Marketing Authorizations for Oral Meprobamate-Containing Medicines

    The European Medicines Agency (EMA) today called on EU national regulatory authorities, including France, UK and Italy, to withdraw their respective Marketing Authorizations (MA) for oral meprobamate-containing medications. The medication has been associated with severe side effects including overdose, coma and death. Meprobamate is a prescription sedative medicine used to treat anxiety, alcohol withdrawal, migraine attacks, disgestive disorders, muscle tensions, muscle ...