Abstract

REGULATORY STANDARDS AND STRATAGIES FOR SUCCESSFUL ABBREVIATED NEW DRUG APPLICATION (ANDA) SUBMISSIONS

A Jaya Tejeswini*, M. V. Nagabhushanam, G. Kavya Latha, K. Pooja, Brahmaiah Bonthagarala, G. Ramakrishna and Y. Ratna Sindhu

ABSTRACT

To identify and evaluate applicable FDA directives and regulatory standards governing ANDA filings for US market. In addition, the objective of the study was to embrace the underlying reasons for frequent ANDA RTRs which makes challenge to small size pharmaceutical firms. The study also aimed to simplify the ANDA preparation steps prior to filing and attain reduced commitments post ANDA approval. Materials and Methods: Various documents describing regulatory requirements, FDA guidances documents applicable for ANDA submissions for US market as presented below. The present study concluded that the current expectations and goals at FDA requires a pristine ANDA submissions from the applicants (no margin for error). However, the challenges faced by the small size start up pharmaceutical firms while preparing for an ANDA submission can be overcome by careful planning, reviewing the available directives noted in this study and utilizing the suggested regulatory strategies presented in this study. Additionally, the suggested regulatory strategies in filing of ANDAs may bring cost savings in addition to preventing potential refusal from the FDA.

Keywords: Abbreviated New Drug Application (Anda) Submissions, US market, FDA guidances, USFDA.