• Regulatory NewsRegulatory News

    Lawmakers Seek Clarity From FDA on Recall of Lifesaving Drug

    Following Takeda Pharmaceuticals’ recall of its hypoparathyroidism drug Natpara (parathyroid hormone) early last month, people who need the drug to stay alive are struggling to find it and ending up in the hospital. Vermont Democrat Senators Bernie Sanders, Patrick Leahy and Rep. Peter Welch sent a letter to the US Food and Drug Administration (FDA) Acting Commissioner Ned Sharpless on Friday seeking more information on how long the recall might last, what short- and lo...
  • Regulatory NewsRegulatory News

    Celgene, Takeda and Others Found in Breach of UK’s Pharma Code of Practice

    When is it OK for a pharmaceutical company to fail to quality check bags stored in a basement for three years before supplying them to pharmacies to use when dispensing the chemotherapy Navelbine (vinorelbine) to patients? Apparently never, according to Tuesday’s rundown of companies breaching the Association of British Pharmaceutical Industry’s (APBI) Code of Practice. In addition to the basement storage fiasco for the French company Pierre Fabre, which the UK’s Pr...
  • Regulatory NewsRegulatory News

    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...
  • FDA Ordered to Approve Watson Laboratories' ANDA for Generic Actos

    • 23 October 2012
    The US Food and Drug Administration (FDA) has been ordered to immediately approve an abbreviated new drug application (ANDA) submitted to the agency by Watson Pharmaceuticals, marking what some analysts are calling a rare defeat for the agency's regulatory discretion. The case, decided by US District Court of Washington, DC, Judge Amy Berman Jackson, regarded the diabetes medication Actos (pioglitazone), one of the most prescribed drugs in the US. Watson, a generics manu...