The multi-attribute method (MAM) is a liquid chromatography-mass spectrometry (LC-MS) based peptide mapping approach used for the identification and quantitation of product quality attributes (PQAs) in therapeutic proteins. The U.S. FDA Center for Drug Evaluation and Research (CDER), Emerging Technology Program (ETP) has assessed the use of MAM in quality control environments and laboratory resources
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
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
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
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
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 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 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
