FDA May Reinstate Oversight Policy as Warning Letter Quality Declines

Since FDA Commissioner Margaret Hamburg ended prior legal review of warning letters last summer, their quality has declined, industry says, prompting the agency to evaluate the policy change. “I have noticed what appears to be a diminution in the quality of warning letters — issues ranging from typographical errors to lack of legal support for assertions,” Jennifer Bragg, partner at Skadden, Arps, Slate, Meagher & Flom, said. In line with Hamburg’s commitment to ensure that the FDA’s work is factually and legally correct, the agency is evaluating the impact of the change, the FDA said.
Washington Drug Letter