NIH and FDA Team Up to Initiate Fast-track Innovations to Speed New Treatments to Patients

  • Date: March 11, 2010
  • Source: admin
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What could have been better? The U.S. Food and Drug Administration (FDA) has teamed up with National Institute of Health (NIH) to pace up the process from scientific breakthrough to launch in market new and innovative medical therapies for patients.

The initiative started by FDA and NIH engages two interrelated scientific disciplines:

  1. Translational science, which deals with the shaping of basic scientific discoveries into treatments; and
  2. Regulatory science, which deals with the development and use of new tools, standards and approaches to more proficiently develop products and to more efficiently evaluate safety, efficacy and quality of products.

In both of these disciplines, biomedical discoveries will turn into products that benefit people.

Establishing Joint NIH-FDA Leadership Council

This initiative includes establishment of a Joint NIH-FDA Leadership Council.  This council will organize joint action of the two organizations on important public health issue and will work hand in hand to ensure that regulatory considerations form an integral component of biomedical research planning, and that the newest science is included into the regulatory review process.

Additionally, the NIH and the FDA have planned to jointly issue a Request for Applications, making $6.75 million dollars available over three years for work in regulatory science.

According to the HHS Secretary Kathleen Sebelius, “Collaboration between NIH and FDA, including support for regulatory science, will go a long way towards fostering access to the safest and most effective therapies for the American people."

Impact of this Initiation

This joint venture will combine NIH’s vast experience supporting and facilitating new discoveries in the laboratory and clinic with the FDA’s more than 100 years of experience and knowledge in the regulation and approval of drugs, biologics and medical devices. Therefore, hope of common people to receive fast paced yet quality medicine can safely get a boost.

Margaret A. Hamburg, M.D., Commissioner of Food and Drugs believes "The FDA plays an essential and unique role in how therapies are evaluated. We are the bridge between biomedical research discoveries and new medical products…We now have a special opportunity--and responsibility--to harness advances in science and technology to support our efforts. We are working in collaboration with the best minds and research institutions available, so that we can better develop and utilize new tools, standards and approaches needed to properly assess the safety, effectiveness and quality of products currently in development or already on the market."

However, The FDA and the NIH will hold a public meeting in the spring to solicit input on how the agencies can work better together.



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