FDA Guidance Snapshots: Launch of a New Pilot
The US Food and Drug Administration (FDA) on Friday unveiled a new pilot program to release “Guidance Snapshots” for a subset of cross-cutting guidance documents on topics related to modernizing drug clinical trials and accelerating drug development.The agency has so far released three of these snapshots, which offer highlights from guidance documents using visuals and plain language. Two of the snapshots are related to guidances providing recommendations to drugmakers on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing. The third snapshot is on developing targeted therapies in low-frequency molecular subsets of a disease.
The two- and three-page snapshots offer a condensed look at what each guidance recommends, why it’s important and when during the development path should one apply the guidance recommendations. Each one also includes Twitter hashtags to create a platform for discussing views on the guidance.
“This pilot program is intended to increase general public awareness and engagement for FDA guidance documents on innovative topics to support the efficient application of the guidance documents’ recommendations,” FDA said.
But the agency also warned that the snapshots should not be misconstrued as a substitute for the actual guidance. The agency also said that the snapshots “should not be used to make drug development decisions.”
Guidance Snapshot Pilot