HHS’ Food and Drug Administration Offers Training for National Drug Regulatory Authorities

March 6, 2007 – Under President Bush’s Emergency Plan for AIDS Relief, the Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services (HHS) has reviewed and approved, or tentatively approved, 36 formulations of generic anti-retrovirals (ARVs) – including three triple-combination formulations – for the treatment of HIV/AIDS.  Once HHS/FDA approves these generic ARVs, use in another country usually requires approval by the national drug regulatory authority, and/or a waiver to import these drugs while review is pending.

To support countries and people in need to get safe and effective generic ARVS as soon as possible, HHS/FDA seeks to hasten the approval or waiver process by providing the appropriate national authorities information about the HHS/FDA review process and its documentation of approval, and by responding to questions and concerns.  From April 16-20, 2007, HHS/FDA will convene the fourth Forum for International Drug Regulatory Authorities, and it is encouraging countries to send an official from their national drug regulatory authorities to participate.  The HHS/FDA Center for Drug Evaluation and Research (CDER) is hosting this forum in Rockville, Maryland.

The forum will exchange drug regulatory information between the HHS/FDA and its counterpart agencies in other countries, and will provide information about the U.S. drug-regulatory process in an organized and integrated manner.  It will explain the role of HHS/FDA, as well as the science, technology, regulations, policies and processes HHS/FDA uses during the review process, including specific discussion and updates on President Bush’s Emergency Plan.

There is no registration fee for this program.  However, attendees will be responsible for their own travel expenses.

For program and registration information, please visit: http://www.fda.gov/cder/audiences/iact/forum/default.htm

For more information about this forum, please contact:
CAPT Justina A. Molzon, J.D.
Associate Director for International Programs
Center for Drug Evaluation and Research
Food and Drug Administration
U.S. Department of Health and Human Services
CDERForum@fda.hhs.gov

Last revised: October 11, 2007