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  • Regulatory NewsRegulatory News

    FDA Warns Wockhardt Subsidiary Over Aseptic Production Issues

    The US Food and Drug Administration (FDA) sent a warning letter to Wockhardt Limited founder Habil Khorakiwala last week over good manufacturing practice (GMP) violations at the company's CP Pharmaceuticals subsidiary in Wrexham, UK. Over the course of a seven-day inspection in October 2015, FDA says its investigator found the company failed to follow its own procedures intended to ensure product sterility. Additionally, the agency says the company's environmental monito...
  • Regulatory NewsRegulatory News

    FDA Warning Letter Reveals Data and Sterility Issues at Teva Plant in Hungary

    The US Food and Drug Administration (FDA) on Tuesday released the warning letter it sent to Israel-based Teva Pharmaceuticals earlier this month, noting instances of data deletion and manipulation at the company’s manufacturing site in Gödöllő, Hungary. Last week, Teva disclosed in an SEC filing that it had received a warning letter on 14 October (four months after the site was banned from shipping products to the US), but now the details of that letter have revealed...
  • As Final Guidance is Released, Deadline for PET Drug Compliance Draws Near

    Manufacturers of positron emission tomography (PET) drugs have until 12 June 2012 to comply with new regulations posted by the US Food and Drug Administration (FDA) on 10 April, reports In-Pharma Technologist . As Regulatory Focus previously reported, FDA has released draft guidance for FDA Oversight of PET Drug Products- Questions and Answers on 27 February, and released final guidance under the same name on 10 April. While the comment period for that final gu...
  • FDA Publishes New Guidance on PET Drug GMPs

    The US Food and Drug Administration (FDA) is releasing a final guidance on positron emission tomography (PET) products to help manufacturers of the drugs meet the agency's requirements for good manufacturing practices. FDA's guidance, Guidance on Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Drugs , deals with sterile manufacturing practices for PET products. "Most PET drugs are designed for parenteral administration and are produc...