Saturday, April 1, 2023
News on Pathogens and Preparedness

CBRN Threats and Challenges – Fall Quarterly Update

The NDIA will host a CBRN Threats and Challenges Fall Quarterly Update Forum on 19 October 2022. This quarterly meeting is set to provide a SECRET-level classified update from government representatives in the Chemical and Biological Defense Program (CBDP). This update will inform industry and government attendees about the CB Threat concerns that the DASD […]

Board of Scientific Counselors, National Center for Health Statistics

Virtual Event Virtual Event

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 […]

In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs

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The FDA will host a meeting on 26 October 2022 to provide additional clarity to the final guidance with respect to Agency expectations for submissions containing Bioavailability information for drug products, and will discuss: Select case studies on various bioavailability (BA) related subtopics (e.g. pharmacodynamic (PD) endpoints, endogenous compound Narrow Therapeutic Index (NTI), biowaivers). Bioavailability […]

Responding to the Climate Change and Health Crisis: A Framework for Academic Public Health

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The Association of Schools and Programs of Public Health (ASPPH) will host a framework launch webinar on Responding to the Climate Change and Health Crisis from 2:00 – 3:00 PM ET on Wednesday, October 26, featuring an expert panel that will discuss some of the challenges and opportunities it identifies. The framework examines climate change […]

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 […]

Public Health Workforce Calculator: Staffing up to Achieve Foundational Services

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In 2021, an analysis of the public health workforce found that state and local governmental public health departments need an 80% increase in their workforce to provide a minimum set of public health services to the nation. In response to this gap, the Public Health National Center for Innovations at PHAB, de Beaumont Foundation, and […]

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 […]

AACC Middle East

Grand Hyatt Dubai Riyadh Street, Sheikh Rashid Road, Dubai

AACC Middle East will be held 5-6 November in Dubai, UAE in partnership with Life Dx. The event that brings the latest in laboratory medicine to the Middle East region and showcases diagnostic innovations at a dynamic exposition. The conference covers a range of timely topics from infectious diseases to big data to prenatal emerging […]

Considerations and Approaches for Obese Patient Populations in Drug Development Studies

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Obese patients are a large segment of the U.S. population and should be included in medical countermeasure and drug development studies. There are presently no clear dosing guidelines for obese pediatric patients. The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) […]