FDA workshop on ANDA deficiencies

Executive Summary

Scheduled for Sept. 24 at the Parklawn Building conference rooms D & E to provide guidance to industry on improving ANDAs. FDA will present preliminary results of study by Evaluation and Analysis staff on chemistry and manufacturing deficiencies found in ANDA submissions. According to Staff Director Douglas Sporn, FDA evaluated a random sample of ANDAs that generated at least two deficiency letters. A total of 1,200 deficiencies, including chemistry, manufacturing and labeling, were found in the 45 ANDAs selected. The completed study may be released before the end of October. The workshop will also include discussion on the Office of Generic Drugs Policy and Procedure Guides.