Defining the INDefinable: US FDA Regulatory Applications
Hosted by the American College of Toxicology and co-host by the ACT Early Career Professional Subcommittee.
Speakers: Arianne Motter, PhD, US FDA; Diana Lac, PhD, Denali Therapeutics
Congratulations, your team has a clinical drug candidate! Now what? Obtaining US FDA approval to begin clinical trials in the US requires the submission of an Investigational New Drug (IND) application that demonstrates the safety and efficacy of your intended new molecular entity or drug candidate. In this respect, achieving regulatory approval with minimal delay can be a challenging process that requires effective collaboration among scientists, regulatory experts, and project managers. In this webinar, we will provide early career professionals with a general understanding of the IND application process and discuss strategies for ensuring a successful submission. Our speakers will provide insights from both Sponsor and health authority perspectives and will introduce a variety of topics, such as the contents of an IND application in accordance with US FDA and ICH Guidelines; the cross-functional teamwork involved in preparing, submitting, and reviewing applications; general timelines; and the value of pre-IND meetings. Some of the most common nonclinical issues leading to a clinical hold will also be discussed. Please join us to hear how experienced toxicologists have worked toward successful IND submissions, and stay tuned for a Q&A session at the end of the webinar that will be open to all attendees.
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