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…
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…
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