Narrator:

FDA’s Center for Drug Evaluation and Research is working with the pharmaceutical industry in a new way to help them adopt scientifically sound new technologies to consistently produce safe, effective and quality medicines.

Dr. Mike:

The FDA has established the Emerging Technology Program, led by the Emerging Technology Team.  This cross-functional team supports industry’s development of innovative approaches in pharmaceutical design and manufacturing. The program provides an opportunity for early dialogue during technology development and prior to the submission of a drug application. This enables us to identify and resolve potential roadblocks early in the process.

Narrator:

By adopting technological advances, the pharmaceutical industry can:

• improve product designs
• create more robust drug manufacturing processes with fewer interruptions
• minimize product failures, and
• provide greater assurance that products will consistently deliver the expected clinical performance.

Dr. Mike:

ETT’s work will help to prevent drug shortages caused by product quality and manufacturing problems.  We have received positive feedback from industry about the ETT, and look forward to continuing productive interactions.  Expanding this program will help reinvigorate our country’s pharmaceutical manufacturing sector.

Narrator:

For more details about the Emerging Technology Program, visit the FDA website.