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FDA Wants Your Advice


Posted in Regulatory and Compliance by Jamie Hartford on June 27, 2014

The agency is seeking proposals to make it globally smarter and faster.


FDA has issued a public call for research proposals to help it stay abreast of health and safety threats from rapidly evolving product technologies and soaring medical product imports. Its notice says that expected funding for the program, not per contract or award, may range from $200,000 to $50 million, depending on congressional appropriations.

Of likely interest to medical device marketers are the program’s request research proposals that would develop and apply simulation models for product life cycles, risk assessment, and other regulatory science uses such as electromagnetic energy and biomaterials, data mining of spontaneous reports, and analysis of electronic health records from large healthcare databases.

Noting that imports of regulated products have risen from 8 million lines in 2002 to an estimated 34 million last year, the program also solicits research proposals to help FDA deal with the global product safety net by determining core competencies for a regulatory workforce and assessing foreign regulatory systems’ performance.
It says FDA wants to “foster global coalitions of regulators, develop strategic approaches to the harmonization and convergence of

standards … and an improved ability to make appropriate regulatory decisions in real time.”

Proposals, FDA says, should focus on one or more of the following areas of interest:

  • 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.

 —Jim Dickinson is MD+DI's contributing editor.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]


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