What Is an FDA Complete Response Letter?

By Kristi Waterworth – Updated Feb 26, 2025 at 2:04 PM

Key Points

FDA complete response letters detail application flaws and data issues, guiding drug approvals.
These letters help investors predict drug approval timelines and potential market entries.
Understanding these letters helps investors gauge risks and opportunities in pharma bets.

When you're investing in pharmaceutical companies or biotechnology, it's important to understand the nuances of this particular industry. Along with learning how to interpret medical testing data, being able to decode an FDA complete response letter can help you better judge where medications and devices are in their approval process.

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Hands lying on a wooden table and holding some pills in one hand and an open pill bottle in the other. — Image source: Getty Images.

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About the Author

Kristi Waterworth has been a contributing real estate and financial expert at The Motley Fool, covering real estate, investing, and personal finance topics, since 2020. Kristi has been interviewed by various TV media outlets and podcasts for her real estate investing expertise – from residential real estate to digital real estate and everything in between. Kristi’s journalist career spans over 25 years, and she has written about real estate investing, homeownership, and home construction specifically for the last decade. She was also previously a licensed Realtor and general building contractor before the Great Recession and housing market collapse. She holds a bachelor’s degree in American history from Columbia College in Missouri.

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