You've identified your product as a candidate for approval via the 505(b)(2) pathway and completed a successful pre-IND meeting. What comes next?
In part two of this webinar series on the 505(b)(2) pathway, Ken delves deeper into IND-enabling activities including CMC, toxicology and PK/PD. Discover tips for harnessing creativity to reference the right data, design and conduct the right studies and get your program to the clinic faster.
This week's FierceBiotech is brought to you by Camargo. |
|
|