Nearly 600 postmarket studies that makers of drugs and biologics were required to perform, or had promised to perform, were running behind schedule as of August, a KFF Health News analysis of FDA data found. The delayed studies involve almost 350 products, many of which remain available while the research meant to answer open safety or effectiveness questions is unfinished.
For patients, that means some medicines are being prescribed without all of the evidence regulators asked for when they approved them. Federal health officials stress that a delay does not by itself mean a product is unsafe, but it can leave doctors and patients making decisions with incomplete information.
