GUIDANCE SNAPSHOTS AT A GLANCE

FDA guidance documents contain the Agency’s current best thinking on a particular topic. To support transparent communication and dissemination of FDA guidance documents, FDA is launching the Guidance Snapshot Pilot for a subset of cross-cutting guidance documents on topics that seek to modernize drug clinical trials and accelerate drug development. Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language. 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.

HOW TO READ GUIDANCE SNAPSHOTS

Guidance Snapshots are a communication tool that provide highlights from guidance documents using visuals and plain language to support transparent communication and dissemination of FDA guidance documents. During the Pilot, Guidance Snapshots will contain a subset of the following key features:

• Explanation of why the guidance document is important
• Highlights from the guidance document
• Educational background about the guidance topic
• Link to the full guidance document
• Drug development timeline for when to apply the guidance recommendations
• Guidance Recap Podcast that describes highlights and background the guidance document explained directly from the authors
• Twitter hashtags to create a platform for discussing views on the guidance
• Link to the FDA docket for providing official comments to the Agency (for applicable draft guidances)

LIMITATIONS OF GUIDANCE SNAPSHOTS

Guidance Snapshots are a communication tool intended to increase general public awareness and engagement for FDA guidance documents. Guidance Snapshots are not a substitute for the guidance document. Guidance Snapshots should not be used to make drug development decisions.