FDA: Complete Response Letters published

In July, the U.S. FDA (U.S. Food and Drug Administration) published an announcement on its website regarding the publication of a large number of so-called "Complete Response Letters (CRLs)".

This shows that the first CRLs published were those that can be regarded as response letters to submissions of drugs (chemical and biological origin) from 2020-2024. These were made accessible in a portal called "openFDA" and presented in an appropriately adapted form for confidentiality reasons. It is already mentioned that further CRLs will follow in the future.

In principle, the provision of CRLs is intended to increase transparency between the applicant and the FDA and thus prevent misinterpretations during the submission process.

Complete Response Letters are issued for a variety of reasons and are sent directly to the sponsor if an authorisation cannot be granted in its current form. Examples of this may include inadequate manufacturing processes, insufficient bioequivalence or failure to ensure drug safety. The relevant points are listed in detail in the CRL and, if necessary, recommendations for remedying the deficiencies can also be listed here.

Please see the FDA communication and the "Complete Response Letters" provided on the "openFDA" website for further information.