Regulatory Roundup: FDA Issues Final Guidance on How to Comment on Advisory Committee Meetings

Dec 16, 2010
By PharmTech Editors

On Dec. 9, 2010, the US Food and Drug Administration issued a final guidance about how to comment during the agency's advisory committee meetings, including the process and timeframe. The guidance finalizes information contained in the 2005 draft document, titled The Open Public Hearing ­ FDA Advisory Committee Meetings ­ Draft Guidance. The new guidance takes effect with meetings held in March 2011.

On Dec. 14, 2010, the US Food and Drug Administration issued a draft guidance for industry on the development of combination drugs. The document provides recommendations for sponsor companies working to codevelop two or more novel drugs to be used in combination to treat a disease or condition. Comments are due within 60 days of the guidance's issue date.