FDA’s New Guidance on Emerging Technology Applications - Webinar CD/Transcript
FDA’s New Guidance on Emerging Technology Applications: What it Really Means for Pharmaceutical Companies
With an eye toward improving product quality, the FDA is inviting drugmakers to join a program to evaluate emerging manufacturing technology. The program would allow for early engagement between the agency and participants to discuss manufacturing design and development issues. Further, it would give agency staff the opportunity to make suggestions on submission content related to emerging technology, according to draft guidance.
As part of the program, a CDER Emerging Technology Team (ETT) will serve as a point of contact for companies interested in implementing novel technology in the manufacture of a drug. The team will answer questions on what the FDA expects to see in submissions, facilitate regulatory review of a new technology, as well as resolve issues that can help inform how the FDA will assess submissions that involve a specific technology.
The emerging technology applications focused on pharmaceutical manufacturing will most likely be divided into four classes:
- Existing technologies used in a novel approach to renovate an aging facility
- Existing technologies that are new to the process used to bridge a severe compliance gap
- Allowable technology changes during facility tech transfers
- Real innovative technology applied to new products
But who is eligible and how does a company apply to become part of the program? Join on us for a comprehensive overview.
This presentation will discuss the most likely scenarios, including:
- Aseptic filling suites /facilities
- All contained and disposable process equipment
- Processing and handling of “combination products”
- Renovation to remediate bioburden, cross contamination, and containment
- Novel therapies /processes
This presentation will also explore the technologies expected to dominate the use of the new guidance:
And finally the presentation will discuss the operations of the ETT and its potential impact on drug shortages and the submission process.
At the end of this presenation you will know:
- Key process technologies that ETT will oversee
- Key facility technologies enabling the continuing march to smaller and cheaper classified spaces
- Compliance decisions affected by the creation of the ETT
- How the ETT is expected to conduct its operations