Tagged with CBER

Denise Gavin – Director, Office of Gene Therapy & Steven Oh – Director, Office of Cellular Therapy and Human Tissue, OTP/CBER, FDA

USA Denise Gavin – Director, Office of Gene Therapy & Steven Oh – Director, Office of Cellular Therapy and Human Tissue, OTP/CBER, FDA

USA As cell and gene therapies move closer to broader clinical reality, questions around manufacturing, scalability, and regulatory flexibility are becoming just as important as the science itself. Denise Gavin and Steven Oh of the FDA’s Office of Therapeutic Products discuss how the agency is adapting its chemistry, manufacturing, and controls…

US Pharma Roundup: Vinay Prasad Returns to FDA; Vaccine Task Force Revived

USA US Pharma Roundup: Vinay Prasad Returns to FDA; Vaccine Task Force Revived

USA The latest stories from healthcare and the life sciences in the US. Vinay Prasad is reinstated as head of the FDA’s CBER following a brief resignation; HHS fires Gray Delany amid fallout from abrupt mRNA contract cuts; the federal Task Force on Safer Childhood Vaccines is revived after three decades…

BIO2023: FDA CBER’s Peter Marks on COVID-19 Regulatory Impact

USA BIO2023: FDA CBER’s Peter Marks on COVID-19 Regulatory Impact

USA During a panel discussion at the BIO International Convention, Peter Marks, director of the US FDA’s Center for Biologics Evaluation and Research (CBER) discussed the positive regulatory outcomes of the COVID-19 pandemic as well as the backlogs it created and the challenges of carrying the lessons learned forward. At…

Peter Marks – Director, Center for Biologics Evaluation and Research (CBER), US FDA

USA Peter Marks – Director, Center for Biologics Evaluation and Research (CBER), US FDA

USA Dr Peter Marks MD, PhD, director of the Center for Biologics Evaluation and Research (CBER) at the US Food and Drug Administration (FDA), highlights the Center’s contributions related to the regulatory science behind vaccine development, including vaccines to prevent COVID-19; the Center’s efforts to facilitate the advancement of the field…