In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft guidance are the following best practices for meeting-related communication with FDA:
As stated in the FDA's draft guidance entitled, "Best Practices for Communication Between IND Sponsors and FDA During Drug Development."
January 25, 2017
After various industry professionals and stakeholders expressed an interest in learning more about the FDA’s views on communications regarding medical products, the Agency has released two draft...
January 24, 2017
On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products. The first draft guidance, entitled “Drug and Device Manufacturer...
January 5, 2016
On December 9, 2015, the FDA released a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely,...