Webinar: US FDA IND Application Strategy & Execution

BLA Regulatory provides comprehensive strategy and operations services to guide you through every step of the regulatory process. We do this by creating a tailored end-to-end approach based on your product and company needs. Our goal is to help move your product efficiently through the drug development cycle.

BLA Regulatory

Submitting an IND application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready?

Attend this seminar to understand how to make sure your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. This virtual seminar contains a collection of everything you need to know to determine whether you are ready to submit your IND and take the next step in the development of your product. In this webinar, you will receive answers to the following questions: <ul><li>When an IND is required? </li><li>How to seek pre-IND advice from FDA? </li><li>What is the minimum required content for an IND submission? </li><li>What to expect during the IND review and after approval? </li><li>How to import your drug into the US? </li><li>How can a solid Regulatory Affairs team help? </li></ul>

Agenda

Definition, Scope, and Types of IND 

Interactions with FDA for Initial IND

Content and Format of IND

IND Review Process and Timelines

IND Maintenance 

IND Drug import 

Role of Regulatory Affairs 

Q&A 

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Webinar: US FDA IND Application Strategy & Execution

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Webinar: US FDA IND Application Strategy & Execution

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