• Regulatory NewsRegulatory News

    GPhA: Congress Needs to Work With FDA to Increase Generic Competition

    The Generic Pharmaceutical Association (GPhA) has offered three key recommendations to Congress on how to work with the US Food and Drug Administration (FDA) to increase generic competition, according to a new report issued Tuesday. ANDA Backlog First, like Hillary Clinton and many others in the past, GPhA is calling on Congress to take action to reduce the backlog of abbreviated new drug applications (ANDAs) awaiting FDA approval. The association says Congress should...
  • New Draft Stability Guidance Calls for Use of ICH Standards

    The US Food and Drug Administration (FDA) has released a new draft guidance document pertaining to stability testing of generic drug products and substances which calls for sponsors to rely on five existing standards promoted by the International Conference on Harmonisation (ICH). Abbreviated New Drug Applications (ANDAs) are commonly used to support generic drug applications under section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) . FDA said it ...
  • 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...