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Guidance on Container Closures Food and Drug Administration Fda Form

Guidance on Container Closures Food and Drug Administration Fda Form

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what are some of the common pitfalls that in can impact approval of applications due to inadequate extractable leachable information [Music] extractable mutual safety assessments can be some of the most challenging review issues in an application requiring a coordinated effort between the CMC and toxicology review staffs from a toxicology perspective based on our experiences reviewing these studies and working with our CMC colleagues we've identified seven common pitfalls that can negatively impact our ability to recommend approval of an application these are number one presence of compounds above the qualification threshold that have not been identified number two inadequate sensitivity of the detection methods number three use of an inappropriate qualification threshold number four in adequate stability data to examine trends in leech holes over time number five the inadequate toxicology justification to support a permissible daily exposure or PDE as described in the IC h gui

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