As a regulatory affairs professional advising various stakeholders on the interpretation and implementation of guidance documents from the FDA, I can safely say that the task is challenging in the best of cases. FDA guidance documents have a tendency to be vague and difficult to decode. As experts, we are always debating about what the guidance is asking and how the contents are to be applied.
In a progressive effort to mitigate these long-standing concerns and bring a level of clarity to its guidance documents, the FDA has created a pilot program called “Guidance Snapshots.” Under this program, the FDA is releasing an initial set of guidance documents that will assist stakeholders in accelerating development. This “snapshot” is designed to highlight key aspects of a particular guidance and make the document more transparent. The snapshot will include the following list of items:
- Link to the full guidance document
- Explanation of why the guidance document is important
- Educational background about the guidance topic
- Link to the FDA docket for providing official comments to the Agency (for applicable draft guidance documents)
- Drug development timeline for when to apply the guidance recommendations
- Highlights from the guidance document
- 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
With such a new program, the FDA is careful to note that “Guidance Snapshots are not a substitute for the guidance document. Guidance Snapshots should not be used to make drug development decisions.”
So far, three snapshots have been released; two 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.
The industry hopes that FDA continues to modernize and partner on such initiatives by creating an environment that is transparent and collaborative. With the release of the Guidance Snapshot program, the agency is taking a step in the right direction. This move will certainly help stakeholders to bring key therapies to patients with a renewed sense of urgency.
Premier Consulting looks forward to continuing to assist our partners with the interpretation of FDA guidance documents and making sure that the information from such sources is properly applied. Please reach out to our regulatory team to get started.
Vice President, Development Strategy