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May 25, 2021
The guidance addresses implementation of amendments made by the FDA Reauthorization Act of 2017.
May 24, 2021
The agency’s human medicines committee concluded sotrovimab can be used to treat COVID-19 in adults and adolescents who do not require supplemental oxygen therapy and are at risk for severe COVID-19.
May 21, 2021
The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.
May 20, 2021
The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.
The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.
The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.
USP worked with a patient advocacy group and a purchasing organization to create a predictive model for improving supply chain resilience for critical pediatric oncology drugs.
May 19, 2021
The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.
May 12, 2021
FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.
NIH reported that an investigational gene therapy developed by researchers from the University of California, Los Angeles and Great Ormond Street Hospital in London can restore the immune systems of infants and children who have severe combined immunodeficiency due to adenosine deaminase deficiency.