FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay Reporter
THURSDAY, July 10, 2025 -- The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as replies to drug and biological product applications submitted to the agency from 2020 to 2024.
The move comes as part of the agency's "broader initiatives to modernize and increase transparency." With the availability of the letters, the public will now have a better understanding of the FDA decision-making process as well as the issues companies need to address before their drugs or biological applications are approved, the agency said.
Complete response letters are issued directly to product sponsors once the FDA finishes all tiers of its review process and concludes that it cannot approve an application in its current state. The issues addressed in these letters are usually related to "safety and efficacy concerns, manufacturing deficiencies, and bioequivalence issues." Not only are the FDA concerns and the product's deficiencies detailed in the letter, but recommendations for addressing them are often provided.
The FDA typically does not make complete response letters public, citing confidentiality, putting the onus on the drug companies to share that information, which they often do selectively. According to a 2015 FDA study, sponsors omitted 85 percent of FDA safety and efficacy concerns in public announcements, and when the FDA called for additional clinical trials, it was not disclosed 40 percent of the time. As a result, other companies may duplicate errors, and investors, clinicians, and patients may make decisions based on incomplete data.
The complete response letters currently available to the public can be viewed at openFDA. Confidential information and trade secrets have been redacted. The FDA is currently working on making additional complete response letters from its archives available.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted July 2025
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