FDA’s transparency initiative increasing disclosure

Drug and device industry has some reservations about the agency's proposals.

The impact of President Obama’s Day One memo calling for “an unprecedented level of openness in government” reached the FDA in June 2009 when the agency announced the formation of a task force to increase transparency of its internal operations.

Phase I of the Transparency Task Force’s initiative culminated in its creation of the website FDA Basics to give the public fundamental information about how the agency operates, regulates and makes decisions.

Pre-Premarket Notice

The 21 draft proposals are divided into topic areas, proposing steps toward greater disclosures in: adverse event reports; docket management process; enforcement priorities and actions; import procedures; inspections; product applications and investigational applications; recalls; and warning and untitled letters.  In whole they promise to open up the FDA’s inner workings to unprecedented scrutiny, which has drug and device companies running scared.

Associate Editor

Melissa Maleske

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