International Journal Of Drug Regulatory Affairs
  • Year: 2021
  • Volume: 9
  • Issue: 2

Interview Questions on ANDA filing

Perfect Pharmaceutical Consultants Pvt. Limited, Chinchwad, Pune, India-411019

*Corresponding author

Online Published on 15 December, 2021.

Abstract

This guidance document provides prominent facts on ANDA filings in FAQ format. It covers aspects like drafting, submission, review, approval of ANDA in question answer format. It is an excellent database for those seeking appointment in large pharmaceutical companies.

Keywords

Drug Master File (DMF), ANDA, NDA, FDA, CDER, OGD