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NEW FDA PILOT PROGRAM – Posting Firm’s Responses to Warning Letters

The FDA is planning to implement a new 6 month pilot program of posting certain company’s responses to Warning Letters on the FDA website.

The pilot program is part of our ongoing efforts to keep the public informed regarding agency activities and to make information publicly available. During this pilot, we will post copies of certain responses to warning letters if the recipient requests that the response be posted on our Web site and submits the response in an appropriate electronic format. We will review the responses and redact certain information to ensure that the responses comply with protections available under the Freedom of Information Act (FOIA).

When the pilot program begins, responses submitted to us: (1) With request that the response be posted, and (2) in the format described in the following paragraphs, will be considered for the pilot program.

After 180 days, we will evaluate the pilot and determine whether the program should become permanent. However, if we experience undue burden in dealing with the process, find that the process is too resource- intensive, or determine that misleading information is being conveyed to the public as a result of the pilot, we may discontinue the program.

For more information on this pilot program you can go to the FDA website at: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-15732.html or contact mdi Consultants, Inc., FDAPP@mdiconsultants.com

.S. AGENT SECTION

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