Industry Wants Faster FDA Review of Letters to Healthcare Providers

An upcoming final guidance on “Dear Healthcare Provider” letters should ensure timely FDA review of them, such as a 24-hour response period, PhRMA says in comments to the draft. The draft guidance recommends companies consult with the appropriate review division when developing the letters, but PhRMA is concerned that in some cases, waiting for input might slow down the delivery of important safety information to healthcare professionals. Further, the recommended two-page limit for the letters may not be adequate in all cases, the trade group says.
Washington Drug Letter