• Regulatory NewsRegulatory News

    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, ...