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 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 […]
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) […]
The FDA's Pulmonary-Allergy Drugs Advisory Committee Meeting will convene on 9 November 2022 to discuss the request for Emergency Use Authorization (EUA) for sabizabulin oral capsule, a tubulin polymerization inhibitor, submitted by Veru Inc., for the treatment of SARS-CoV-2 infection in moderate to severe COVID-19 infections at high risk of acute respiratory distress syndrome. Sabizabulin […]
The 70th IAEM Annual Conference & EMEX will be held 11-17 November 2022 in Savannah, Georgia. The program features more than 150 speakers providing plenaries and breakout sessions under the umbrella theme, “Emergency Management Unmuted.” In addition, All DHS/FEMA pre-/post-conference training courses, the IAEM Leadership Symposium, IAEM K-12 Workshop, and the Ascenttra Advanced Exercise Design […]
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 […]
The Biomedical Advanced Research and Development Authority (BARDA) 2022 Industry Day virtual event will be held 15-16 November 2022. BARDA, a component of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), invites you to participate in the annual conference to learn about U.S. Government […]
The World Antimicrobial Awareness Week and U.S. Antibiotic Awareness Week take place 18-24 November 2022. Antimicrobial resistance (AMR) occurs when bacteria, viruses, fungi and parasites change over time and no longer respond to medicines, making infections harder to treat and increasing the risk of disease spread, severe illness and death. As a result of drug […]
The U.S. Food and Drug Administration FDA will host an Industry Day on 6 December 2022 to discuss a Broad Agency Announcement (BAA) for state of the art advancements in technology, materials, processes, methods, devices, and techniques in pharmaceutical regulatory science. FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and […]
