Have you ever had a tough time understanding some of the more complex guidance documents that the FDA issues that fall outside our specific areas of expertise? Yes, if we are being completely honest, it has probably happened to us all at one time or another. Fortunately, it’s about to get easier thanks to an innovative new program that is a clear reflection of the old cliché, “A picture is worth a thousand words.”
In the highly informational article, “FDA Watch: CDER to Launch Guidance Snapshot Pilot Program,” authored by Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc., you’ll learn about what the new program will be featuring and what you can expect to see in these condensed “looks.”
This Guidance Snapshot Pilot Program is being initiated by the FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of Translational Services (OTS), partnered with CDER’s Office of Communications (OCOMM).
According to the FDA, the goal “is to provide a guidance snapshot in plain language and include graphics to help break down the contents of the guidance contents.”
Better understanding leads to better results and it’s our guess that this program is a worthwhile step in that direction.
