FDA outlines plan to be more transparent to industry

The Food and Drug Administration is undertaking 19 new actions and considering five additional proposed actions as part of its broad effort to improve transparency to regulated industries.

The plans are detailed in a new report, "FDA Transparency Initiative: Improving Transparency to Regulated Industry," posted on the FDA website and published in the Federal Register today.

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Public comments are welcome until March 8.

The 19 actions span three major areas of activity. Six pertain to FDA communications, four to the product application review process, two to guideline development, two to the regulations development process and five to the import process.

For example, under a new policy, FDA said that if it receives a question via e-mail about how it operates, it will strive to provide a response within five days. For complex questions, it will acknowledge the inquiry and indicate how long it will take to respond.

FDA also said it would update its online organizational and leadership charts at least quarterly and post copies of any presentations by FDA employees to outside groups at events sponsored or co-sponsored by FDA.