Article

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

FDA Issues Final Guidance on How to Comment on Advisory Committee Meetings

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information contained in the 2005 draft document, titled The Open Public Hearing ­ FDA Advisory Committee Meetings ­ Draft Guidance.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On Dec. 14, 2010, the US Food and Drug Administration issued a draft guidance for industry on the development of combination drugs.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 totreat a disease or condition. Comments are due within 60 days of the guidance's issue date.

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
Glenn Wright, President and CEO, PDA
© 2025 MJH Life Sciences

All rights reserved.