Posted: 21 Jun 2016 01:09 AM PDT By Kurt R. Karst – It’s been a little more than 4.5 years since we first revealed in a December 11, 2011 FDA Law Blog post the fruits of our hunt for the mythical list of pending proceedings under the Drug Efficacy Study Implementation (“DESI”) program, which started decades ago after enactment of the 1962 Kefauver-Harris Drug Amendments. The list, dated August 2006, identifies 17 items. As we explained in our previous post, the list is of interest to some drug manufacturers given the enforcement policy FDA laid out in the Agency’s September 19, 2011 “Compliance Policy Guide: Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs.” We recently came across an updated version of FDA’s List of Pending DESI Proceedings. The new list, which updates the August 2006 version (updating the previous 17 items and adding 2 more proceedings), is included in correspondence that FDA sent to the Staff of the House Energy and Commerce Committee in March 2016 in response to some questions the Committee had about the DESI program. FDA’s response also addresses two questions from the Committee – “For how many DESI drugs have there been successful NDA filings?” and “How many DESI drugs are still on the market?” – which we provide further below. In the 10 years since the August 2006 list was put together, FDA seems to have made some headway in completing pending DESI proceedings. Of the 17 proceedings identified in the August 2006 list, 7 are now identified as closed. A total of 12 DESI proceedings (including 2 additions) are now identified as pending, including one proceeding that has been the subject of some recent activity.
For how many DESI drugs have there been successful NDA filings? |
martes, 21 de junio de 2016
FDA Law Blog: A New and Improved (Updated) List of Pending DESI Program Proceedings
FDA Law Blog: A New and Improved (Updated) List of Pending DESI Program Proceedings
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