Thompson Interactive - 15 Days Until Enforcement: Responding to 483s and Warning Letters from the New FDA

Your company has just been issued a 483. When you respond, and what you say in your response, can reduce the risk of a warning letter. Or perhaps your company’s response to a 483 was not satisfactory to the FDA, and now you do have a warning letter. What now?

In this 90-minute audio conference, former FDA deputy associate commissioner for Regulatory Operations Steve Niedelman and attorney Cathy Burgess will discuss what you must do, from the time the investigator signs her name until the FDA indicates “no further action is necessary.”