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.
Why You Should Attend:
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
Who Should Attend:
Regulatory Affairs Departments
Quality Departments
Research and Development Departments
Clinical Personnel
Manufacturing Departments
Auditors
Clinical Research Associates (Monitors)
Legal Personnel