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David Elder, vice-president, technical at PAREXEL, discusses the best way to productively participate in a regulatory meeting with FDA.
Q. How can my company participate productively in a regulatory meeting with FDA?
A. An invitation to a regulatory meeting with FDA might not be preferred, but it isn't entirely negative. FDA management initiates a regulatory meeting to inform responsible individuals about how one or more products, practices, processes, or other activities are considered to be in violation of the law (1). FDA views regulatory meetings as another tool to achieve prompt, voluntary compliance, typically initiated either to advise and educate prior to a warning letter or to provide additional assistance or direction after a warning letter. In the former example, FDA may use the regulatory meeting tool to deal with small firms, new firms, firms with a good history of compliance, or firms who make lower-risk products. In the latter example, FDA may use the regulatory meeting after a follow-up re-inspection found progress but lack of full compliance—the meeting would be another attempt to achieve or accelerate compliance before determining that it is necessary to initiate an enforcement action (e.g., injunction, seizure).
There are some steps that should be taken to maximize one's chances of a productive and successful regulatory meeting.
A company's measure for success for a regulatory meeting should actually be quite consistent with FDA's measure for success: a clear commitment to address all concerns and to achieve and sustain compliance with the law and regulations.
1. FDA, Regulatory Procedures Manual, Section 10-3, 2011, www.fda.gov/ICECI/compliancemanuals/regulatoryproceduresmanual/default.htm#_top, accessed June 17, 2013.