For those of us in regulated industry, we all treat guidance from FDA with as much reverence as the tablets that Moses carried down from Mt Sinai. However, for those of us who are not employed by FDA, the processes underlying the issuance of these guidances is very opaque and mysterious, and, for those involved in drug development, at exactly what point in the drug development process they should be applied can be a subject of debate.
In an effort to increase transparency and to communicate to their stakeholders in plainer language, FDA announced a pilot program last week to release “Guidance Snapshots” for a subset of cross-cutting (across Centers) guidances related to modernizing clinical trials and (hopefully) accelerating drug development. During the pilot, these Snapshots will contain a subset of the following 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 of 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)
FDA states that “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 also cautions that “Guidance Snapshots are not a substitute for the guidance document. Guidance Snapshots should not be used to make drug development decisions.”
To date, three (3) snapshots have been released; two (2) are on drug interactions with cytochrome P450 enzyme systems for new drugs during clinical and in vitro testing, and the third is on developing targeted therapies in low frequency molecular subsets of a disease. (Please note, dear readers, that the link for the third guidance is incorrect on the pilot program announcement-FDA, please get on that.) At the time of this writing, the two guidances on CP450 drug interactions studies have not only a snapshot of the guidance, but also an associated podcast (!). We applaud FDA for their very tech-forward pilot and am sure it will prove to be very informative to those involved in new drug development.