Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA has published over 200+ redacted Complete Response Letters (CRLs) issued to drug applicants. The published CRLs include applications for drugs or biological products between 2020 and 2024.
FDA issues CRLs for drug applications on completion of the review cycle when there are deficiencies due to which the application is not approved. The deficiencies could be for various reasons including manufacturing deficiencies, facility deficiencies, bioequivalence issues, safety and efficacy concerns. Making the CRL available can greatly help drug product developers and applicants to get greater insight into the FDA’s expectations, review process and most common deficiencies cited.
The published CRLs are redacted for trade secrets and confidential commercial information. The initial batch of published CRLS of applications (which are further approved) are accessible for download at openFDA. FDA would be publishing additional CRLs with the objective of providing greater transparency into its decision-making process and predictability.
FDA News Release on Publishing CRLs
The Approved and Unapproved CRLs can be accessed from https://open.fda.gov/apis/transparency/completeresponseletters/?utm_medium=email&utm_source=govdelivery
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