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# Consultants’ Advice on How to Talk to FDA
- URL: https://www.fdaweb.com/consultants-advice-on-how-to-talk-to-fda/
- Published: 2020-10-08T12:00:00.000Z
- Updated: 2026-09-14T16:31:54.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5147832

An online post from Govzilla, data intelligence consultants, gives tips for regulated companies on how to talk with FDA officials and how to listen when FDA officials talk to them. The [post](https://govzilla.com/blog/2020/01/how-to-talk-so-that-fda-will-listen-and-how-to-listen-when-they-talk-advice-that-could-be-worth-millions/?ref=fdaweb.com) is based on information presented at a 9/2019 Regulatory Affairs Professionals Society meeting by former FDA team leader **Robert Seevers**.

Assuming that a strong, organized data package is being submitted, Seevers said it is important to understand the FDA meeting and review processes and expectations; be aware of government regulations and guidance; have respect for agency personnel; use the appropriate vehicles to submit changes; and use appropriate communication channels.

In his presentation, Seevers explained why companies should not: 

- contact their drug reviewer directly;
- ignore their device reviewer if contacted directly;
- complain about the cost of meeting a regulatory requirement;
- get caught in a lie;
- fail to check available guidance;
- submit changes requiring prior approval in an annual report;
- raise questions in a meeting with FDA that were not in the briefing document;
- fail to be adequately prepared for an FDA meeting;
- tell FDA that the company’s approach was OK for a European Union submission; and
- blow off regulators’ advice.