FDA Still Trying To Become More Transparent

FDA Still Trying To Become More Transparent

October 4th, 2011 // 1:38 pm @

As part of an ongoing ‘transparency initiative‘ launched by FDA commish Margaret Hamburg, several agency officials met with their counterparts at the US Environmental Protection Agency and the US Department of Labor to find additional ways to organize and present information that so many people have difficulty finding on the FDA website.

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The effort took on new meaning earlier this year when President Barack Obama issued a memo on regulatory compliance that requires federal agencies to make publicly available compliance info easily accessible, downloadable, and searchable online (here is the FDA response and here are draft proposals issued by a task force).

But after meeting with the EPA and DOL and reviewing steps taken by these agencies to promote greater public access to enforcement and compliance data, the FDA has now come up with an additional set of draft proposals. There are eight altogether and these should be of interest, notably No. 7, the FDA should explore ways to better utilize social media, such as Facebook and Twitter, as well as agency webinars and automatic e-mails.

Other proposals include whether the FDA should explore posting additional data compilations or analysis, beyond the most common inspections observations or warning letter compilations. The agency also wants to explore how to present compliance and enforcement data graphically, and better utilize mobile apps to draw more people to its webpages, as well as encourage data analysis.

What else? The FDA is also seeking comment on whether it should explore different ways to improve data quality and facilitate more timely data disclosure by expediting data entry, expediting inspection review and classification, and updating the data more frequently. And the agency wants to know whether it should explore the use additional or more specific search criteria, or more sophisticated search capabilities, to make its inspections database easier to use and analyze.

Source: Pharmalot


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