Are you anxiously waiting to hear from FDA about your PMTA?
Ideally, the next time you hear from the FDA it would be to know that you have market authorization, unfortunately, the FDA’s next communication can be a deficiency letter. This requires you to provide additional information in order for FDA to determine whether it can provide market authorization for your products. Your response to FDA’s deficiency letter is critical. It will determine the trajectory of your review, so you need to develop the right strategy and tone in your response.
But how, without insight into your specific deficiencies, do you prepare? You will not have a lot of time to address PMTA deficiencies so how do you anticipate the FDA’s data needs and begin to address them before receiving the deficiency letter?
Join Labstat’s Scientific Advisor, Dr. Willie J. McKinney, and Labstat President, Michael Bond for a discussion on how to prepare for and develop your response to a PMTA deficiency letter including understanding expected FDA testing requirements and turn-around times. Learn what to do now based on responses received, understand what you might hear and what FDA’s next level of testing might include.
This is part 2 of a special webinar series focusing on CTP’s requirement of PMTA submissions.