Compliance with the FDA requirements for pharmacovigilance reporting is essential. It is also complex. As this brief summary makes clear, there are laws, regulations and guidances that must be understood and met. These standards, especially the regulations and guidances, change with relative frequency. Thus, it is important that any company and/or individual must ensure that they have available the most current versions of all applicable standards. Therefore, while this Chapter provides a reasonable framework of the legal requirements, it, alone, cannot be the basis upon which up-to-date compliance with the FDA requirements is established.

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