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It's in the mail -- Responding to an FDA warning letter

Wisconsin companies regularly and eagerly await responses from the FDA to requests for authorization of clinical trials involving investigational products, submissions for premarket clearance of medical devices, and other submissions and applications. But a different type of FDA letter -- a warning letter -- is much less welcome.

Warning letters provide wri......

Full article >>> event report is not a warning letter.

A warning letter can come from one of the FDA's district offices, such as the Minneapolis District, or one of its product-based centers, such as the Center for Drug Evaluation and Research.

Warning letters generally are sent to the highest known official in an organization (e.g., president or CEO). Warning letters usually require a response w......

Full article >>> as specific as possible, and explain what actions the company has taken and plans to take, it is important to follow these steps if a warning letter arrives:

Review the warning letter very carefully. Evaluate the specific violation or violations alleged, and what action is demanded.
If the letter seems unclear, contact the listed FDA contact person for clarification.
A careful......

Full article >>> h the agency, but also leave the company particularly vulnerable to an FDA enforcement action.

Patricia Kaeding, an attorney, was an associate chief counsel at the FDA in Rockville, Md from 1993 to 2003. FDA & Your Business appears monthly on WTN.
The opinions expressed herein or statements made in the above column are solely those of the author and do ......

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'"/> By Patricia Kaeding 08/12/05

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