Chasing Compliance: The Global Regulatory Podcast kicks off season two with a two-part episode on abbreviated new drugs applications (ANDAs). Our guest today, Sandra Kircus, walks us through the basics of ANDA submissions, the ANDA approval process, and common challenges associated with ANDA submission. She also touches on the differences between drug applications (NDAs), traditional ANDAs, and petitioned ANDAs. Following this, we discuss agency communication. Agency communication is often considered one of the most challenging and nuanced aspects Chemistry, Manufacturing, and Controls (CMC) regulatory activities. Sandra discusses this in detail in the second half of the episode, providing her perspective on agency communication and some tips for success.

Sandra is a Director in the CMC Division of Global Regulatory Writing and Consulting. Sandra started her career as a chemist in the FDA. After leaving the FDA, Sandra helped several companies establish and maintain regulatory and quality systems. Throughout her 20 year career in the industry, Sandra supported a wide verity of regulatory pathways, however, one of her principal focuses was on CMC-related submissions and submission strategy, including ANDAs. Sandra She holds a B.S. from the University of Montevallo and PhD in Chemistry from UNC Chapel Hill.

2:05 – ANDA Basics

5:05 – What’s the difference between an NDA and ANDA? Sandra provides additional Background on ANDAs.

9:50 – In the case where two companies are simultaneous developing a drug, can one company file an ANDA soon after the other receives approval on a NDA?

12:05 – What are petitioned ANDAs?

15:35 – What does the ANDA approval process involve? What can one expect?

18:55 – Sandra provides several tips for agency communication.

20:15 Tips for 1st time ANDA Submissions

24:15 Communication with the FDA

30:10 – Sandra’s first tips on improving the ANDA preparation and submission process. To be continued in Part 2.