Building a Productive Relationship with the FDA: Beyond the Science
While the fate of an application is undoubtedly tethered to the science behind it, how effectively this application winds its way through the regulatory labyrinth is hugely linked to the working relationship that exists between the sponsor and the FDA.
A mature, global animal health company wanted to expand into human healthcare. The company was unsure whether their lead product was ready to advance to IND-enabling activities. The company also lacked expertise in human clinical product development.