FDA Programs Support New Manufacturing Technologies

Help is on the Way- FDA Programs Support New Manufacturing Technologies

July 5, 2021

By ScienceDocs NIH SBIR grant writer Dr. Marcy

If your company has new technology related to the manufacture and administration of therapeutics, there are two FDA programs to support the implementation of innovative procedures. For regulatory applications to be submitted to the Center for Drug Evaluation and Research (CDER), the Emerging Technology Program was instituted in 2014. For applications planned for submission to Center for Biologics Evaluation and Research (CBER) the CBER Advanced Technologies Team (CATT) was established in 2019. Both programs work collaboratively with companies at an early stage to anticipate and resolve challenges related to new technology development and provide guidance for eventual regulatory submissions.

Is my company eligible?

The programs are aimed at technologies that are new to regulatory review by the agency. These may include improvements in product technology, analytical methods, manufacturing processes, or control strategies. The new technology may lead to an improved product with respect to safety, identity, strength, quality or purity.

How do I sign up?

Both the CDER Emerging Technology Program and CBER Advanced Technologies Program use a competitive submission process to select suitable candidates. There are no admission application deadlines, and agency engagement can start early in development, even before a clinical candidate has been identified.

Eligible companies for the Emerging Technology Program will be planning to submit an investigational new drug (IND), original or supplemental new drug application (NDA), abbreviated new drug application (ANDA) or biologic license application (BLA), or an application-associated drug master file (DMF) to be reviewed by the Center for Drug Evaluation and Research (CDER).

Companies should submit a meeting request (5 page limit, including figures and tables) as described in the Emerging Technology guidance document (https://www.fda.gov/media/95444/download). The request should be at least three months before the anticipated regulatory submission, and the document should contain:

– a brief description of the new technology, and why it is substantially unique

– an explanation of how the new technology has the potential to improve product safety, identity, strength, quality or purity

– a summary of the development plan, including anticipated challenges

– a timeline for regulatory document submission

Applications should be sent electronically to: CDER-ETT@fda.hhs.gov; an agency decision will follow within 60 days.

For planned submissions to Center for Biologics Evaluation and Research (CBER), applications are made to the CBER Advanced Technologies Team (CATT). Submit a request (2 page limit, including figures and tables) with the following:

– a brief description of the new technology, and why it is substantially unique

– an explanation of how the new technology will impact improvements in biologic product manufacturing, characterization, quality, safety or efficacy

– a summary of the development plan, and any questions about anticipated regulatory, technical or other challenges for implementation

Applications should be sent electronically to: Industry.Biologics@fda.hhs.gov, and include CATT in the subject line.

Streamline the Process

Both the CDER Emerging Technology and CBER Advanced Technologies Programs offer opportunities to identify and resolve regulatory issues for novel manufacturing technologies. The engagement with FDA can facilitate regulatory evaluation for new technologies, and ultimately de-risk your company’s development pipeline.

Useful Sources

CDER Emerging Technologies Program Overview

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program

CDER Emerging Technologies Guidance Document

https://www.fda.gov/media/95444/download

CBER Advanced Technologies Program Overview

https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-program

CBER Advanced Technologies Program Instructions for Submissions

https://www.fda.gov/vaccines-blood-biologics/industry-biologics/cber-advanced-technologies-team-catt

Keywords

FDA regulatory approval, Emerging Technology Team, Advanced Technology Team