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  • Regulatory NewsRegulatory News

    Reassessing Benefit-Risk: FDA Preps for New Guidance

    US Food and Drug Administration (FDA) and pharmaceutical industry experts gathered Thursday in Silver Spring, MD, to discuss how FDA assesses the benefits and risks of new drugs from the preclinical to postmarket phases. The meeting was conducted as part of FDA preparations in drafting new guidance in FY 2020 on the benefit-risk assessment of new drugs and biologics. Theresa Mullin, associate director for strategic initiatives at FDA’s Center for Drug Evaluation and ...
  • Regulatory NewsRegulatory News

    Report Outlines New FDA Device Evaluation System, Coordinating Center

    A national medical device evaluation system planning board, created in part by the US Food and Drug Administration (FDA), released a new report on Monday outlining how it plans to develop such a system and a center to coordinate such efforts. Both the national medical device evaluation system (NMDES) and the coordinating center are part of a larger goal of FDA’s to expedite the generation and dissemination of reliable medical device data, including real-world evidence, i...