FDA Transparency Initiative Moves to Phase Three

March 18, 2010
Angie Drakulich
ePT--the Electronic Newsletter of Pharmaceutical Technology

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry.

In the final phase of its transparency initiative, the US Food and Drug Administration seeks additional public comments about how it can increase its interactions with regulated industry, according to a Mar. 12, 2010 announcement in Federal Register.

FDA launched the Transparency Task Force in June 2009 with a transparency blog and website, which constituted the first phase of the project. The second phase involved two public meetings held in June 2009 and November 2009 to garner feedback from industry and the general public. The overall goal is to develop recommendations for making the agency’s “activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information,” according to an agency press release on the subject. The agency is expected to issue draft proposals soon regarding how it will increase its transparency in the long term.

Before it issues draft proposals, the agency would like to hear additional comments from industry. FDA recommends that industry read or listen to a series of sessions that were held with industry representatives in January 2010. The audio files and transcripts are available at www.fda.gov/transparency and at www.regulations.gov.

FDA is particularly interested in recommendations about how it can:
·        Train and educate regulated industry about the FDA regulatory and guidance-development processes
·        Maintain open channels of communication with industry routinely and during crises
·        Provide useful and timely answers to industry questions about specific regulatory issues

Comments are due on Apr. 12, 2010 and can be submitted at www.regulations.gov.
 
See related PharmTech articles:

FDA Bares All (blog post)

Transparency and Safety (blog post)

FDA Enters the Blogosphere with New Transparency Task Force (blog post)