Cathy Burgess presented this audio conference sponsored by AHC Media. Cathy discussed the pattern of recent warning letters and gave participants pointers on FDA’s current areas of focus. In addition, Cathy provided tips on how to avoid warning letters and how to respond if you receive one. The following topics were covered during the presentation.
- Will FDA take enforcement action or “wait and see”?
- Are these inconsistent approaches?
- Can industry anticipate how the agency will respond to a problem?