Faculty: Carolyn Troiano
FDA provides 4 programs for accelerated drug approval, each with a specific set of requirements and considerations. Drugs must be for serious conditions that fill an unmet medical need and can be approved based on a surrogate endpoint, or biomarker.
A drug qualifies for BTD review if it is intended to treat a serious condition, and preliminary clinical evidence indicates it may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies. BTD status affords the requestor more frequent meetings and written communications with FDA, rolling review, intensive guidance on efficient drug development and involvement of FDA senior managers to expedite the process.
Rolling Review enables a company to submit completed sections of its BLA or NDA for review by FDA. The eCTD format enables a company to account for all components, inter-dependencies, linkages and the lifecycle of a submission, facilitating the process.
Only 70% of all BTD requests are met with FDA approval. The standard for BTD is not the same as for drug approval, and preliminary clinical data are key. Specific study designs can aid in demonstrating substantial improvement. Early and effective communication with FDA is key to success.
Why You Should Attend:
During this presentation we will 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. The format and rules governing BTD request will be discussed along with success and challenge factors. The training is designed to provide industry best practices related to all aspects of the BTD application process.
Areas Covered in the Session :
Who Should Attend:
This 90-minute online course is intended for professionals in the Medical Device, Biotechnology, Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Anyone who is involved in the development, testing, manufacturing, storage, handling and distribution of product must understand and conform to FDA requirements for data quality and integrity.
Finally, anyone who is acting as a consultant or contractor to a company in an FDA-regulated industry should attend to ensure they are able to bring the most current knowledge and expertise to their assignment.