FDA NanoDay Symposium 2022
Virtual Event
The FDA NanoDay Symposium 2022 will be held on 11 October 2022. The event will address drug development of products that contain nanomaterials in their formulation and how the newly
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9 events found.
Government Hosted
Quality Considerations for MAM for Therapeutic Proteins
Virtual Event
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.
Board of Scientific Counselors, National Center for Health Statistics
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
In-Depth Look at Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs
Virtual Event
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
Best Practices: Modeling Approaches to Support Generic Product Development
Virtual Event
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
Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting
Virtual Event
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
Considerations and Approaches for Obese Patient Populations in Drug Development Studies
Virtual Event
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
FDA Review: EUA for Oral Sabizabulin for High-Risk COVID-19 Patients
Virtual Event
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,
BARDA Industry Day 2022 – BID22
Virtual Event
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