Snapshot: A New Guidance Document Program From The FDA

By Nach Davé

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.