FDA Offers Guidance on Contacting It About New Products

Sponsors of investigational new drug (IND) applications should first consult existing documents for answers before asking FDA staff, to save the agency’s limited resources for complex, challenging issues, according to a draft guidance issued Dec. 4.

The draft guidance, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development: Guidance for Industry and Review Staff,” is a joint effort by the Food and Drug Administration’s drug and biologics centers to describe “timely, transparent, and effective communications,” which the agency said may bring safe and effective drugs to the American public sooner.

“Because these communications are often opportunities to ...