FDA Updating Science Used in Medical Product Development

Will also support new approaches in manufacturing

Hoping to be both safer and quicker in moving ideas to products, the FDA released a "Strategic Plan for Regulatory Science," on August 17. The agency says it's a "sweeping modernization of the science used in developing and evaluating products critical to the nation's health, economy, and security."

The agency intends to collaboratively enhance the process for developing and evaluating promising new products and novel materials from fields such as cell therapy, tissue engineering, genomics, personalized medicine, advanced computing, and information technology.

"As new discoveries yield increasingly complex products, this strategic plan ensures that our experts are equipped to make science-based decisions resulting in sound regulatory policy," said FDA Commissioner Margaret A. Hamburg, M.D. "It positions us to foster innovation through better science without compromising our high safety standard."

The FDA will modernize its plan for regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products. This plan identifies eight priority areas:

  • Modernize Toxicology to Enhance Product Safety
  • Stimulate Innovation in Clinical Evaluations and Personalized Medicine to Improve Product Development and Patient Outcomes
  • Support New Approaches to Improve Product Manufacturing and Quality
  • Ensure FDA Readiness to Evaluate Innovative Emerging Technologies
  • Harness Diverse Data through Information Sciences to Improve Health Outcomes
  • Implement a New Prevention-Focused Food Safety System to Protect Public Health
  • Facilitate Development of Medical Countermeasures to Protect Against Threats to U.S. and Global Health and Security
  • Strengthen Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions about Regulated Products

The FDA will also support new approaches to improve product manufacturing and quality. Specifically it will collaborate with external partners by addressing each of the following needs:

  1. Enable development and evaluation of novel and improved manufacturing methods
  2. Develop new analytical methods
  3. Reduce risk of microbial contamination of products

As part of the FDA's support for Quality by Design the agency said it is now working on three new areas to support increased manufacturing quality. The first is a continuous processing where materials constantly flow in and out of equipment. The second is the use of process analytical technology to monitor and control processes, as opposed to the current method of just testing products. The third is the development of new statistical approaches to detect changes in process or product quality.

Another area of improvement the agency is looking into is how it communicates health information to consumers, particularly as communication technologies rapidly evolve and change the way people receive that information.

"New technologies provide unprecedented opportunities to prevent and cure disease and to grow our high tech economy," said FDA chief scientist Jesse Goodman, M.D, M.P.H. "This plan will help turn advances in science into products that benefit people, and help FDA assure that happens more quickly and safely. It is win-win-win, because it will help the public, the agency, and developers of new products."

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