30. August 2018
LIVE WEBCAST Tuesday, October 2, 2018 at 11am EDT, 10am CDT, 4pm BST, 5pm CEST Can't make the live webcast? Register now and view it on-demand after the air date. Event Overview The Inactive Ingredient Database (IID) provides information on inactive ingredients present in FDA-approved drug products and is used by industry as an aid in developing drug products. How can sponsors gain a better understanding of the FDA requirements and avoid lengthy review cycles, unnecessary requests for...
18. November 2016
The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy. The US FDA has almost cleared a backlog of 4000 excipient formulations in its Inactive Ingredient Database (IID) and wants drugmakers to help ensure ongoing accuracy. The IID is intended to be a definitive searchable catalogue of every excipient that has ever been used in a US Food and Drug Administration (FDA) approved drug. The...
12. October 2016
FDA and the excipient industry are giving more thought to how the inactive ingredient database (IID) can be improved to better support the development of emerging dosage forms, including drug delivery devices such as transdermal patches, metered dose inhalers, nasal sprays, and implants. A session was held at the 2016 IPEC-Americas/ExcipientFest Conference, held in late April in Baltimore, Maryland, to explore the regulatory issues encountered in formulating emerging dosage forms and how the...
23. April 2015
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....