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Navigating the FDA Regulatory Requirements

Navigating the FDA Regulatory RequirementsThis three-part video series provides an overview of best practices for navigating the regulatory maze of the FDA.

Get help with complex regulatory requirements for new drug (IND) and device (IDE) development; learn how to optimize your communication with the FDA for IND and IDE applications; and gain useful tools and resources necessary for finding successful pathways from discovery to clinical implementation.

This course is presented by Heather Hatcher, IND/IDE Navigator. Learn more about IND/IDE Navigation Services.

Best Practices for Investigational New Drug (IND) Exemption Studies, IND Preparation, and Maintenance

This video discusses the regulatory context of new drug clinical investigations; how to determine when an IND is required; and identifies the steps in the IND application process and possible FDA decisions on those applications.

Understanding Medical Devices and Investigational Device Exemption (IDE) Studies

This video discusses the regulatory context of device clinical investigations; how to determine when an IDE or other regulatory pathway (i.e. 510(k) or de novo designation) is required; and identifies the steps in the IDE application process and possible FDA decisions on those applications.

Best Practices and Communication Methods when Dealing with the FDA

This video describes strategies for meeting the FDA’s expectations for timely interactive communications with IND/IDE sponsors; discusses how to differentiate appropriate types of advice to seek from FDA during development of drugs and medical devices; explains expectations for the timing of FDA response to IND/IDE inquiries; and discusses expectations for appropriate methods and frequencies of communications between FDA and the IND/IDE sponsor during drug and medical device development.

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View a range of educational opportunities available, including all upcoming CTSI courses, external resources from the CTSA Consortium, and more in our Educational Offerings listing.