How to Apply for a Breakthrough Therapy Designation and Win It
Date: March 25, 2025
Duration: 60 Minutes
Time: 12 PM EST
- 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
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.
- 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

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Prices are in US Dollars.
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