FDA takes microsite back to 'Basics'

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The FDA unveiled the first fruit of its transparency initiative with FDA Basics, a microsite aimed at demystifying the agency's workings for the public.

“We'd like to see this pull people into the process we have at FDA for developing policy,” said principal deputy commissioner Joshua Sharfstein, who chairs the agency's Transparency Task Force. “This may be one avenue to catch people who ordinarily wouldn't be able to find the way to comment on something.”

FDA Basics (www.fda.gov/AboutFDA/Basics) will feature FAQs and Q&As about the agency, short videos explaining agency activities, conversations with agency personnel about their work and a series of monthly webinars by senior officials from different FDA centers starting this month. Topics to be covered include access to investigational drugs, the inspection process and safeguarding against BSE (mad cow disease).

It's the first of a three-phase transparency initiative launched by commissioner Margaret Hamburg last spring as part of the Obama administration's broader commitment to openness. Phase 2, which will deal with disclosure of sensitive information like clinical trials and postmarket surveillance data, will likely be completed by the end of February, Dr. Sharfstein said, and Phase 3, dealing with the agency's transparency to regulated industries, will probably wrap up “maybe a couple months after that.”

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