The U.S. Food and Drug Administration holds more than 2,000 meetings a year with 1,800 companies who are all trying to get the information they need to get a drug approved or a medical device cleared.
Meetings happen at various stages, typically at key milestones of a product’s development. With so many FDA meetings, it can be hard to get on the FDA’s calender. But it’s not enough to get the meeting, said Mark Baumgartner, senior director, global regulatory affairs for GlaxoSmithKline (NYSE:GSK). You’ve got to make the most of the meeting time that you have. A growing number of these meetings are with “emerging sponsors,” typically smaller, venture capital-backed companies that have never taken a drug to market. The FDA realizes that emerging sponsors need more guidance than large pharmaceutical companies. If you’re one of them, a little preparation — actually, a lot of preparation — goes a long way.
To read the full, original article click on this link: The one question to never ask the FDA … and other tips for FDA meetings
