http://www.forbes.com/sites/johnlamattina/2014/12/01/should-the-fda-force-drug-makers-to-discuss-their-clinical-trials/

Companies are not required to meet with the FDA to discuss their trial design. Nor are they required to follow their recommendations.

As revealed in a recent research letter to the Journal of the American Medical Association (JAMA) ), of the 35 drugs approved from February 1, 2011 to February 29, 2012, companies met with the FDA to discuss pivotal studies for 28.