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FDA will invest $500 Million on Regulatory Innovation

  • July 10, 2017

  • FDA just announced  they are going to invest a $500 million innovation fund authorized in the 21st Century Cures Act, which will require approval from Congress.

    FDA Commissioner Scott Gottlieb said in a blog post that the agency’s plans for investing the innovation fund are to improve public health by facilitating biomedical innovation and to reduce drug costs by cutting the burden of unnecessary regulation.

    The innovation fund will include $25.8 million for patient-focused drug development, and $95.3 million to regulatory science initiatives, including the advancement of drug development tools such as biomarkers. It also plans to streamline the regulation of targeted drugs for rare diseases.

    The largest expenditure from the innovation fund, $168.2 million, is set aside for FDA initiatives designed to improve the collection of evidence about safety and efficacy. This includes supporting the design and implementation of novel clinical trial designs, and enabling the use of real world evidence to support approvals of new indications for approved drugs among other areas.

    We look forward to bringing you updates throughout all of our conferences.