IPEC-Americas Publishes Position Paper on FDA Inactive Ingredient Database
Issues related to inaccurate and incomplete information on excipients referenced in the U.S. FDA Inactive Ingredient Database (IID) and FDA policies and guidance related to the review of inactive ingredients in ANDAs continue to create confusion for the pharmaceutical industry. As a result, pharmaceutical companies filing drug applications have encountered longer review cycles, unnecessary requests for additional safety studies/information and/or Refuse to Receive letters from the Agency.
