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U.S. Department of Health and Human Services

Science & Research

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3. Support New Ways to Improve Product Manufacturing and Quality


Inspectors testing new manufacturing technologies and manufacture of biological products

Application of novel science and technologies is leading both to innovation in manufacturing and to innovative products that are often complex.  To foster these innovations, FDA is conducting research – collaborating with industry and academia – to assess how these new technologies affect product safety, efficacy, and quality, and using the information to inform development of regulatory policy relevant to these innovations.

Analytical technologies are rapidly changing and leading to dramatic improvements in sensitivity, resolution, and precision in the determination of product structure and the detection of contaminants.  FDA is supporting the application of novel technologies to product development and innovative analytical approaches to improve product manufacturing and quality through active research intramurally and through collaborations by addressing the following needs:

  • Enabling the development and evaluation of new and improved manufacturing methods;
  • Developing new analytical methods; and 
  • Reducing risk of microbial contamination of products.