Complete Response Letters – When Your Submission Application Isn’t Granted
On July 10, 2025, the Food and Drug Administration (FDA) notified the public it would publish more than 200 decision letters, known as complete response letters (CRLs) [1], in response to applications submitted to the FDA for approval of drugs or biological products between 2020 and 2024. This provides the public with insight into their decision-making process as well as the most common deficiencies cited that needed resolution before the application is approved. The FDA aims to enhance the manufacturing process for establishments by streamlining predictability, improving future submissions, reducing review timelines, and helping companies avoid similar trending issues.
What are CRLs? CRLs are issued to the product sponsors (e.g., A sponsor who has submitted for a Biologics License Application – BLA, for commercialization) when FDA completes their review cycle and determines that it cannot grant approval of an application in its current form. The FDA issues CRLs for reasons such as:
safety and efficacy concerns,
manufacturing deficiencies,
and bioequivalence issues.
The deficiencies are detailed in these letters, and may also include recommendations for addressing them.
These published letters can be accessed at FDA’s “openFDA” website. Follow the links below for more information on accessing these redacted letters.
How to use the API: Click here [2] .
How to construct the Query: Click here [3] :
How to download the Data: Click here [4] :
How to search the Endpoints: From the API page, select the appropriate Endpoint category to open and click on each section for further instructions. Here, a Medical Device was used as an example.
Click here [5] :
Taking a further look, while these decision letters were for drugs that were eventually approved, a little over twenty (20) letters had not been previously published and were now available for public access. On September 4, 2025, FDA released eighty nine (89) more CRLs from 2024 to current. The FDA also confirmed that “going forward, the agency will promptly release newly issued CRLs, and when approving applications, will release all CRLs associated with that application. The agency will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications. All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names [6] .” With this, concerns for future challenges from publishing CRLs may contain confidential and sensitive information and if not properly redacted, lead to lawsuits or create issues for companies regarding their final disclosures as well as impact stakeholders.
We’ll continue monitoring this FDA topic. Keep checking back for updates as we learn more!
See you next time!
References
[2] https://open.fda.gov/apis/
[3] https://open.fda.gov/apis/query-parameters/
[4] https://open.fda.gov/apis/downloads/