Conclusion

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Chapter: Pharmacovigilance: Legal Basis - United States

Compliance with the FDA requirements for pharma-covigilance reporting is essential. It is also complex.


CONCLUSION

Compliance with the FDA requirements for pharma-covigilance reporting is essential. It is also complex. As this brief summary makes clear, there are laws, regulations and guidance documents that must be understood and adhered to. These standards – particularly the regulations and guidance documents – change with relative frequency. Thus, it is important that companies and individuals charged with phar-macovigilance compliance ensure that they have the most current versions of all applicable standards. Therefore, although this chapter provides a reason-able framework of the legal requirements pertain-ing to pharmacovigilance activities, close scrutiny of the laws, regulations and guidance documents on adverse event and other safety reporting standards is essential.

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