FDA Announces Public Workshop: FY 2018 Generic Drug Regulatory Science Initiatives

On May 24, 2018, “FDA will hold a public workshop that will provide an overview of the current status of the regulatory science initiatives for generic drugs and will provide an opportunity for public input on research priorities in these topic areas. FDA is seeking input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the reauthorization of the Generic Drug User Fee Amendments (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing the fiscal year (FY) 2019 Regulatory Science Plan.”

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