Most of us are trying to simplify our schedules and remove meetings from our calendars. However, there is one scenario where the potential for more meetings is actually a good thing. That is when you are preparing to submit a regulatory application to a health authority, such as an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA). Getting the FDA’s input into your application prior to submission is a critical step in the process. Because the meetings are typically scheduled for about an hour to an hour and a half, making good use of your time with the health authority is key.
The effects of the U.S. government shut down and the impact on how FDA is working is all anyone seems to be talking about. Chicken Little is clucking that there is no end in sight! For the small company, delays can be disastrous. However, product development can and should continue! Now is a great time to think strategically to achieve your next development milestone(s).