The Food and Drug Administration (FDA) is a frightening group to many companies. In some people’s minds, they represent roadblocks and obstacles to getting their product to market. But it does not have to be that way. Learning how to maintain a good relationship with the FDA will help any business leader work with the regulatory group to the benefit of both parties.
Know the Rules
Leverage your internal or external resources to review the regulations and guidelines applicable to your food or pharmaceutical item before you even speak to the FDA. You want to work alongside people who know how to properly interpret the documentation created by the FDA so that you can prepare for their eventual feedback and questions. Also, by learning the rules, you are showing the FDA that you plan to be helpful and cooperative throughout the approval process.
Be Smart With Your Communication
You should be organized in your communication with the FDA. Try not to give them data dumps, but rather stress the key messages of your product. Help them to understand your process. Furthermore, you should follow the FDA’s feedback every step of the way. This will tell them that you take the regulatory body seriously. That kind of mutual respect is vital in how to maintain a good relationship with the FDA.
Have a Positive Approach
There is no reason to think of the FDA as your adversary. You both want to bring the safest, most complete product to market. When you speak with representatives of the FDA, think of them as your partner, someone who has your best interests in mind. Throughout its history, the FDA has worked to improve products. Why would they do anything but improve yours?
Create Multiple Lines of Communication
Your regulatory project manager (RPM) will likely be the first point of contact between your business and the FDA. But it should not end there. To show the FDA your respect, people at your senior executive level should also get involved in the discussions. You can even go the extra mile and attend professional conferences and workshops hosted by the FDA. There you can better understand their perspective and show your willingness to learn.
