Those of us in the industry are usually reasonably technically savvy and can understand some of the more complex guidance documents that the FDA issues. However, there are times that even those among us in the industry, depending on our individual academic tracks and professional experiences, whether regulatory, CMC, bioanalytical, pharmacokinetics, medical, and on and on, may have a hard time grasping some of the concepts outside our areas of expertise. Just think about how hard it might be to understand some of the guidances issued by the FDA for those stakeholders that are not on the front lines but also have a need to access the Agency’s guidance documents. Well, my guess is that both of these groups may benefit from this innovative new program.

The idea is to provide a guidance snapshot in plain language and include graphics to help break down the guidance’s contents. According to the FDA, “[T]he snapshot offers a condensed look at:

• What each guidance recommends
• Why the guidance is important
• Background information about the guidance topic
• When to apply the guidance recommendations during the development process
• Where to submit official comments (for draft guidance documents only)”

Creation of the Guidance Snapshot Pilot Program is being initiated by the FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of Translational Sciences (OTS), partnered with CDER’s Office of Communications (OCOMM).  The first two snapshots in the pilot program will be for the following guidance documents:

• Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs
• Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

Expect to see more on the pilot program soon but, for now, you can read more about it and the vision for the program here. I think we all might benefit from seeing some plain language; it might assist us in better getting the messages of the guidance documents. How often have we read an FDA guidance document and thought, “what does that really mean?” Of course, it will still be essential to fully read the guidance documents but a little assistance may be a good thing because, as they say, a picture is worth a thousand words.

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Robert Pollock, M.S., is Senior Advisor, Outside Director to the Board at Lachman Consultants. He joined Lachman Consultants following a distinguished career with the FDA and the Public Health Service. His FDA experience, culminating as the Acting Deputy Director of the Office of Generic Drugs, enables him to provide expert advice and assistance on all aspects of FDA and Regulatory filings. Mr. Pollock is well-versed in the intricacies of International Harmonization Issues, regulatory strategies, standards and filing issues, resolution of FDA regulatory matters, as well as in the resolution of patent/exclusivity issues.