Compliance Corner: Follow These 11 Steps To Prep For FDA Regulatory Meetings

Longtime industry expert Steve Niedelman of the law firm King & Spalding offers manufacturers pointers so they’re not caught flatfooted during regulatory meetings with the US agency.

MT1712_Compliance Tab_552489361_1200.jpg

The US Food and Drug Administration in recent years has taken to holding regulatory meetings with device makers rather than immediately sending warning letters. Preparing for these meetings is critical and will increase the chances of a positive outcome, a longtime industry expert advises.

“Regulatory meetings can be a win-win for both parties, for FDA as well as for industry” – as long as...

More from Regulation

More from Policy & Regulation