Friday, September 30, 2022
News on Pathogens and Preparedness

Study Data Standards Update for FDA CBER

Virtual Event Virtual Event

FDA's Center for Biologics Evaluation and Research (CBER)  will host a free virtual format workshop on 5 October 2022 entitled Study Data Standards Update for CBER: Your Guide to a Successful Submission. CBER will discuss CBER’s support and requirement starting March 15, 2023 for the Standard for the Exchange of Nonclinical Data (SEND) , which […]

Epidemics That Didn’t Happen

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Join Resolve to Save Lives for a dynamic conversation to mark the release of the second edition of “Epidemics that Didn’t Happen.” This virtual event and new report will illustrate how global and local investments in preparedness, combined with swift, strategic responses by public health authorities, can transform the trajectory of outbreaks, saving lives and preventing suffering. […]

Board of Scientific Counselors, National Center for Health Statistics

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The CDC has announced the Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS) will convene 24 October 2022 in a live broadcast public meeting. The Board is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the […]

Best Practices: Modeling Approaches to Support Generic Product Development

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FDA and the Center for Research on Complex Generics (CRCG) will host a free public workshop on October 27-28, 2022: Best Practices for Utilizing Modeling Approaches to Support Generic Product Development The purpose of this two-day workshop is to discuss and illustrate how generic product developers can utilize modeling approaches in conjunction with in vitro […]

Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting

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On November 2, 2022, the committee will discuss the Center for Drug Evaluation and Research (CDER) Quality Management Maturity (QMM) program. QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. CDER has proposed the development of a rating system that will […]

Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing

Virtual Event Virtual Event

The FDA and Product Quality Research Institute (PQRI) will host a webcast workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing on 14-16 November 2022. Future pharmaceutical manufacturing may occur not only in large manufacturing facilities; it may occur in smaller, more geographically distributed facilities or even at the point of […]