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Generics and biosimilars will slow the overall pace of drug spending growth this year, even though U.S. prescription drug spending is slated to rise by 4 to 6 percent year-over-year in 2022. Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni outlined the center’s budget priorities in fiscal year 2023 in a webinar hosted this week by the Alliance for a Stronger FDA. Read More
Repeated COVID-19 boosters simply aren’t a practical way to deal with the shape-shifting SARS-CoV-2 virus, according to members of the FDA’s Vaccines and Related Biologics Advisory Committee. Read More
Two draft guidelines from the International Council for Harmonization (ICH) were released yesterday for public comment, one on pediatric extrapolation in clinical trials and the other on calculating compound-specific acceptable intakes. Read More
The FDA issued a final guidance yesterday for sponsors of drugs and biologics for the treatment of chronic hepatitis B that expands upon a November 2018 draft. Read More
The FDA has withdrawn its Emergency Use Authorization (EUA) for the GlaxoSmithKline and Vir Biotechnology COVID-19 monoclonal antibody treatment sotrovimab based on data indicating that it isn’t effective against the Omicron BA.2 subvariant. Read More
In one of his first public presentations as FDA commissioner, Robert Califf outlined his vision for enhanced use of health data as the way to improve health outcomes. Read More
The Office of Inspector General (OIG) within the Department of Health and Human Services has called for the increased use of biosimilars to reduce spending by the federal government’s Medicare Part D prescription drug program. Read More
Today, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will attempt to grapple with the problem of SARS-CoV-2’s vexing ability to escape vaccine coverage. Read More