Abstract
“For-cause” inspections are initiated during the review of bioequivalence (BE) data submitted to Abbreviated New Drug Applications when possible scientific misconduct and study irregularities are discovered. We investigated the common reasons for initiating “for-cause” inspections related to the clinical, analytical, and dissolution study sites associated with BE studies. This information may help the pharmaceutical industry to understand the root causes of compliance failures in BE studies and help them to improve compliance with FDA’s regulations, thereby facilitating more rapid approval of safe and effective generic drugs.
References
U.S. Food and Drug Administration. Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products—general considerations. 2003. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf. Accessed 8 Aug 2012.
Approved products with therapeutic equivalence evaluations. 31st edition. Washington, DC: US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs. 2009. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf. Accessed 8 Aug 2012.
USFDA. Title 21 of the Code of Federal Regulations (CFR), Part 320. Bioavailability and Bioequivalence Requirements.
Liu Q, Davit B, Cherstniakova S, Dandamudi S, Walters J, Lee C, Raines K, Ren K, Williamson L, Conner D. Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDA. AAPS J. 2011. doi:10.1208/s12248-011-9312-7.
FDA/ORA Bioresearch Monitoring Information Page, http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/default.htm. Accessed 8 Aug 2012.
Disclaimer
This article reflects the views of the author and should not be construed to represent FDA’s views or policies.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Li, B.V., Davit, B.M., Lee, C.H. et al. Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration. AAPS J 15, 10–14 (2013). https://doi.org/10.1208/s12248-012-9415-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1208/s12248-012-9415-9