FDA’s 2011 Guidance Agenda Released

• Date: December 22, 2010
• Source: Admin

FDA has released its Guidance Agenda for 2011 - it has been published in the Federal Register. The agenda functions as a Guide to Guides. The agency is not bound to adhere to the schedule. Thus, the Guidance on the Internet and Social Media is listed in the 2011 agenda although it figured in the 2010 agenda.  This throws up the following two possibilities:

• The draft guidance that the Division for Drug, Marketing and Advertising (DDMAC) hoped to release by the year-end may not be released. There was always a suspicion that some elements of the release were outside the jurisdiction of DDMAC
• More than one draft guidance could emerge.

In fact, a two-day public meeting in November 2009 covered the topic in detail and many believed that the draft guidance would not address the issues that emerged at the said meeting.  At best, multiple guidances divided among different subject matter jurisdictions might emerge. 

“Comparative Claims in Drug Promotion”, and “DTC Television Advertisements – DTC Pre-Review Program” figure under the category “Advertising” in addition to the guidance on “Promotion of Prescription Drug Products Using Social Media Tools”. 

By way of clinical trial designs, topics are slated for “Non-inferiority Trials” and “Adaptive Trial Designs”. Considerable activity is allocated for tobacco given FDA’s new authorities in this area.   However there is no suggestion of creation of a regulatory pathway for biosimilars. 

Regulations

The Food and Drug Administration (FDA) publishes its annual guidance document agenda. This list is published under FDA’s good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones. The general public can submit either electronic or written comments on this list and on any agency guidance document at any time.

Source:

http://www.eyeonfda.com/eye_on_fda/2010/12/fda-publishes-guidance-agenda-for-coming-year.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+eyeonfda/

http://edocket.access.gpo.gov/2010/pdf/2010-30623.pdf

http://en.wikipedia.org/wiki/Food_and_Drug_Administration_Modernization_Act_of_1997