How to Apply for a Breakthrough Therapy Designation and Win It

Date: March 25, 2025
Duration: 60 Minutes
Time: 12 PM EST

The Breakthrough Therapy Designation (BTD) is perhaps one of the most impactful incentives from the FDA as it helps get the product to market much faster than any other expedited approval pathway. Once a drug is successful in getting the BTD, the non-clinical and clinical requirements for market approval are significantly reduced. The applicants can request special meetings with FDA to discuss the development steps, and become eligible for priority review. However, getting a BTD is not easy; there is about 70% rejection rate for applicants of BTD; the success of BTD award depends a lot on the disease targeted and the product being developed, and BTD request requires significant resources from the applicant.

Areas Covered in the Session:

Assessing the eligibility of a product for BTD
Best practices for format, style, and organization of the BTD application
Best time in the development timeline to apply for the BTD
Pros and cons of applying for the BTD
What to do when the BTD is rejected: process to re-apply and appeal
Managing public information related to the BTD
Common errors and potential solutions

Why should you attend:

This webinar, presented by a leading regulatory affairs expert with successful BTDs, discusses FDA expectations from BTD requests, the best practices to write a BTD request, and pros and cons of applying for a BTD. The session will highlight key regulatory requirements, dos and don’ts, common areas of concern, and trouble-shooting BTD requests using case studies and examples from the presenter’s vast experience helping companies big and small in successfully applying for a BTD. The format and rules governing BTD request will be discussed along with success and challenge factors. The training is designed to provide a well-rounded training to all stakeholders in all aspects of the BTD application process.

Who will benefit:

Regulatory Affairs Personnel
Quality Assurance Personnel
Vice-Presidents, Directors and Managers
People interested in investing in the FDA-Regulated Industry

Speaker: Mukesh Kumar

PhD, RAC | CEO, FDAMap

For more info, fill the box below. We will contact you within 24 hrs.

Webinar Fee

Single Registration

$189

Group Registration (5 Persons)

$599

Group Registration (10 Persons)

$999

Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.

Terms & Conditions to register for the Webinar

Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com

Payment

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Cancellations & Substitutions:

Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.

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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.