Tagged with CDE

Sarah Yim – Director, Office of Therapeutic Biologics and Biosimilars, CDER, FDA

USA Sarah Yim – Director, Office of Therapeutic Biologics and Biosimilars, CDER, FDA

USA The FDA’s Sarah Yim discusses the evolving regulatory landscape for biosimilars in the US, the shift toward analytical-heavy reviews over large clinical studies, the legislative push to simplify interchangeability, and the agency’s commitment to increasing market competition and patient access through streamlined development pathways. My goal, and the FDA goal…

US Pharma: FDA Appoints New CDER Director; AstraZeneca Pledges $50B; Moderna Scraps Japan Plant; Sarepta Defies FDA; Measles Spurs R&D Revival

USA US Pharma: FDA Appoints New CDER Director; AstraZeneca Pledges $50B; Moderna Scraps Japan Plant; Sarepta Defies FDA; Measles Spurs R&D Revival

USA The latest stories from healthcare and the life sciences in the US. The FDA names Stanford’s George Tidmarsh as the new head of CDER; AstraZeneca commits USD 50 billion to new US manufacturing and R&D projects; Moderna cancels its planned mRNA facility in Japan; Sarepta refuses to halt Elevidys shipments…

China: CDE Rejected 542 Drug Applications Last Year

China China: CDE Rejected 542 Drug Applications Last Year

China Accestra Consulting’s Zhao Lu* looks back on a year in which China’s Center for Disease Evaluation (CDE) rejected a record-breaking number of drug applications, explores some of the main reasons behind these rejections, and suggests how applicants can avoid them in future. In 2021, China’s Center for Disease Evaluation…

Janet Woodcock – Director, Center for Drug Evaluation and Research (CDER), US FDA

USA Janet Woodcock – Director, Center for Drug Evaluation and Research (CDER), US FDA

USA In an exclusive interview, Janet Woodcock, head of the Center for Drug Evaluation and Research (CDER) at the US Food & Drug Administration (FDA) outlines how the world’s gold-standard agency for regulatory science is adapting to game-changing and often extremely expensive new therapies, why a sizeable impact from data and…