Pilot on Drug Guidance ‘Snapshots’

FDA has launched a new pilot program to simplify public awareness about guidance documents that seek to modernize drug clinical trials and accelerate drug development. FDA says the Guidance Snapshot Pilot is a “communication tool that provide highlights from guidance documents using visuals and plain language.” During the Pilot, the 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 document
• Drug development timeline for when to apply the guidance recommendations
• 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 (for applicable draft guidances)

The pilot launched with the following three snapshots available:

1. In Vitro Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Snapshot
2. Clinical Drug Interaction Studies - Cytochrome P450 Enzyme-and Transporter-Mediated Drug Interactions Final Guidance Snapshot
3. Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease Final Guidance Snapshot