RTR

Overcoming Challenges in the Generic Pharmaceutical Industry: A Lesson on RTR and ANDA Resubmission

Overcoming Challenges in the Generic Pharmaceutical Industry: A Lesson on RTR and ANDA Resubmission

Today, we are going to share an important lesson from the world of generic pharmaceuticals – the journey of an ANDA (Abbreviated New Drug Application) and what happens when a company encounters a Refuse-to-Receive (RTR) letter from the FDA.   The RTR letter serves as a vital communication tool, highlighting specific issues that need attention…