• OTC Topical Pain Relievers Can Cause Dangerous Reactions, Say Regulators

    Regulators with the US Food and Drug Administration (FDA) have sent out a warning to consumers indicating that over-the-counter topical pain relievers such as BENGAY and Icy Hot have in some cases led to dangerous skin reactions. After receiving numerous reports of consumers suffering mild to severe chemical burns from products containing menthol, methyl salicylate or capsaicin, FDA said it had combed its adverse event reporting databases and found 43 cases in which a ...
  • FDA Moves to Reduce Backlog of ANDAs

    The US Food and Drug Administration (FDA) is moving to clear a massive backlog of abbreviated new drug applications (ANDAs), used by companies looking to market generic versions of FDA-approved products, in advance of new resources expected under a duo of user fee bills expected to be passed by the Congress within the next few months. In a 13 June Federal Register posting, the agency said it wants to disregard any ANDA which it deems to have been abandoned by virtue of...
  • CDER Provides Guidance to FDA Staff on How to Expedite Review of ANDA Supplements

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has issued a new Manual of Policies and Procedures (MAPP) document in which the agency describes to internal staff the guidelines for expediting the review of Abbreviated New Drug Application (ANDA) supplements. FDA's 5240.1: Requests for Expedited Review of Supplements to Approved ANDAs , posted  27 April, describes how ANDA supplement sponsors "may ask FDA to expedite ...
  • New Bioequivalence Recommendations for Popular Drugs Released by FDA

    The US Food and Drug Administration (FDA) released updated draft guidances on bioequivalence (BE) recommendations for numerous popular products. The BE studies are used to support abbreviated new drug applications (ANDAs). The draft guidances, released 25 January, use the processes described in Bioequivalence Recommendations for Specific Products (May, 2007) to formulate the BE recommendations. As a result of that guidance, FDA has released BE recommendations for sev...