by Robert Seevers | Feb 21, 2018
This is the second entry in a running series about U.S. Food and Drug Administration guidance documents. View the first entry, “What is an FDA guidance document?”, here. “I’m from the government, and I’m here to help you.” This short phrase instills fear...
by Robert Seevers | Jan 18, 2018
This is the first in a series of blog entries about U.S. Food and Drug Administration (FDA) guidance documents. As it happens, FDA has published a number of draft and final guidances in the past few months. We will provide an in-depth analysis of a few guidances that...
