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
The FDA Vaccines and Related Biological Products Advisory Committee will convene on 6 October 2022 in open session to discuss the Strain Selection for the Influenza Virus Vaccines for the
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
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.
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
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
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
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
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
