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Progress of FDA’s Compliance/Enforcement Data Transparency Initiative Will Be Spurred by Refined Road Map from Working Groups

May 29th, 2014

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The impact of FDA’s compliance/enforcement data “transparency initiative” will continue to increase with the help of a road map released by the initiative’s working groups in late April.

One place where the impact of the initiative has already been clearly manifested is in a comprehensive public database of FDA interactions with pharmacy compounders (IPQ April 14, 2014).

The database is updated in nearly real-time and contains a list of all compounding firms that have been inspected since the agency’s inspection blitz began in the wake of the meningitis outbreak (IPQ March 10, 2013).

Included are links to all associated: ● 483s ● warning letters ● recall notices ● FDA and company press releases, and ● referral letters to state boards of pharmacy with recommended follow-up actions.

Improving internal software tools to facilitate data quality, promote more rapid reviews and posting of compliance information, and make the data more user-friendly, is one of eight facets of the transparency initiative that separate teams have been working on.

The late-April report outlines the progress the teams have made and provides their recommendations on how to advance the various facets.

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