FDA Guidance Digest

High-value regulatory guidance summaries and interpretation posts.

Core Guidance Summaries

• Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause
• FDA Guidance Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
• Considerations Regarding Non-Interventional Studies for Drug and Biological Products Guidance for Industry
• Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Framework and Context Posts

• Comment on Framework for FDA’s Real-World Evidence Program - part 1
• Comment on Framework for FDA’s Real-World Evidence Program - part 2
• Comment on ICH M14 Guideline - part 1
• Comment on ICH M14 Guideline - part 2

How to use this page

• Use these posts as briefing notes before protocol meetings.
• Send links to cross-functional stakeholders to align on evidence expectations.
• Pair each guidance post with one method post from Problem Index to convert policy into analysis decisions.