Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug Administration.
"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.
Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 7520 Standish Place, Rockville, MD 20855, USA. bing.li@fda.hhs.gov
Bing V
BV
Li
Barbara M
BM
Davit
Christina H
CH
Lee
Santhosh K
SK
Pabba
Chitra
C
Mahadevan
Hoainhon T
HT
Caramenico
Sam H
SH
Haidar
Aida L
AL
Sanchez
Aaron W
AW
Sigler
Ethan M
EM
Stier
Dale P
DP
Conner
D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration