Authored by our Senior Manager – Regulatory Operations, Prabu Selvaraj, we are delighted to have had this article published in the peer reviewed International Pharmaceutical Industry journal. The article explores the considerations when submitting a 2253 submission and accelerated pre-submission following the FDA mandate around OPDP submissions in June 2021. Are you ready?
Please complete the form to download a copy of the article and learn more.
Please complete the form to download a copy of the article.
Published in International Pharmaceutical Industry
Issue 4 | Issue4 | November, 2021 | Pages 18 - 20