Newsletter - February 10, 2022
FDA Pushes Back on Drug Approval Based on 100% Clinical Data from China
FDA is strongly pushed back on attempts by a Chinese company seeking approval for a new cancer drug based on clinical data from one Phase 3 study conducted in its entirety in China. While this decision may seem contrary to earlier statements by FDA leaders that were interpreted to mean that FDA would accept pivotal data...Read More
FDA Will Start Unannounced Inspections in India and China “Soon”
In response to a report from the GAO chastising FDA for its inadequate foreign audit practices particularly in India and China, FDA promised to start unannounced inspections at manufacturing plants in India and China in “early 2022”. FDA also promised to actively hire more inspectors able to travel to India and China by offering...Read More
FDA Pushes Back on Drug Approval Based on 100% Clinical Data from China
FDA is strongly pushed back on attempts by a Chinese company seeking approval for a new cancer drug based on clinical data from one Phase 3 study conducted in its entirety in China. While this decision may seem contrary to earlier statements by FDA leaders that were interpreted to mean that FDA would accept pivotal data...Read More
FDA Will Start Unannounced Inspections in India and China “Soon”
In response to a report from the GAO chastising FDA for its inadequate foreign audit practices particularly in India and China, FDA promised to start unannounced inspections at manufacturing plants in India and China in “early 2022”. FDA also promised to actively hire more inspectors able to travel to India and China by offering...Read More
