• Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Looks to Resolve Vaccine Shortages (12 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Calls on Regional Regulators to Work to Resolve Vaccine Shortages The China Food and Drug Administration (CFDA) has called on its regional offices to take steps to resolve the country’s vaccine supply shortage. The request comes at a time when CFDA and the vaccine industry it regulates are adapting to the changes that were proposed in response to the scandal that rece...
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    FDA Clears Path for Botox Imitators

    A new guidance document released today by the US Food and Drug Administration (FDA) wants to help some biopharmaceutical manufacturers smooth the wrinkles out of the drug development process for products containing botulinum toxin, better known by many as Botox. The guidance, Upper Facial Lines: Developing Botulinum Toxin Drug Products , is specifically intended only for those botulinum products intended to temporarily improve the appearance of wrinkles in the "upper ...
  • Two Receive Debarments for FDCA Violations

    Two doctors are on the receiving end of debarment orders issued by the US Food and Drug Administration (FDA) after the agency found both to have injected patients with an unapproved and illegally obtained version of Botox (botulinum toxin) in violation of the Federal Food, Drug and Cosmetic Act (FDCA) . The two had separately obtained illicit versions of Botox-commonly used as a cosmetic agent to reduce wrinkles-from Toxin Research International, Inc (TRI). The first, ...