Clinipace

Great article in PharmTech Talk about FDA’s Transparency Initiative (FDA Bares All), with phase 1 launched today.

The US Food and Drug Administration has unveiled the first phase of its Transparency Initiative: a new website called FDA Basics provides the public with detailed information on what the agency does, who works there, and how regulated products are approved for the marketplace.

Based on over 900 responses to it’s public call for comments, the agency has developed a three phase plan to deploy it’s transparency initiative.

Next up (phase 2, expected at the end of February) will involve a set of recommendations for the FDA Commissioner to make the agency’s activities more transparent, useful, and understandable to the public.

Followed by (phase 3, expected this summer) a set of recommendations for the FDA Commissioner, with this set focusing on what information can be made more transparent to the regulated industries.

In a complex process, all players (ie, trial sponsors) must commit to transparency, otherwise the good intentions of the FDA will not be realized.

Were is industry in this transparency discussion?