In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug applications submitted between 2020 and 2024.
The release marks an important step in the agency’s broader initiative and provides a clearer view into why certain pharmaceutical products have not received approval.
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CRLs are decision letters that outline specific concerns or deficiencies identified by the FDA during its review process, often encompassing efficacy and safety issues, manufacturing problems or bioequivalence discrepancies.
Details on deficiencies will be listed in the letters, including references for tackling them.
By disclosing these CRLs, sent to product sponsors, the FDA provides an insight into common pitfalls that sponsors must rectify to gain approval for their application.
Due to confidentiality around pending applications, sponsors could misrepresent significant details from FDA feedback when communicating with investors and other interested parties.
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By GlobalDataA study conducted by FDA researchers in 2015 found that companies did not publicly acknowledge 85% of safety and efficacy concerns raised by the agency.
Information on additional clinical trials for safety or efficacy requested by the FDA was undisclosed almost 40% of the time.
FDA Commissioner Marty Makary stated: “For far too long, drug developers have been playing a guessing game when navigating the FDA.
“Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with a goal of bringing cures and meaningful treatments to patients faster.”
The first set of CRLs related to previously approved applications is now available to the public accessibility via openFDA, although they are redacted for sensitive information.
The agency continues its work on releasing further CRLs from its archives while exploring additional methods for enhancing public access to its evaluative processes with better transparency.
