Regulations

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Chapter: Pharmacovigilance: Legal Basis - United States

The FDA regulations contain provisions establishing a system for reviewing reports of adverse events and submitting them to the FDA.


REGULATIONS

The FDA regulations contain provisions establishing a system for reviewing reports of adverse events and submitting them to the FDA. Only certain reports must be sent to the FDA, depending on the nature of the event and the source of the information. The regulatory requirements for reporting adverse events related to investigational and marketed products are largely the same and are intended to be consistent with international standards. On 14 March 2003, FDA published a proposed regulation that would amend pre- and post-marketing safety reporting regulations (68 Fed. Reg. 12406). One primary objective of the proposal was to further harmonize the FDA require-ments with evolving international standards. Notably, the proposed regulation would create a new require-ment that manufacturers collect and report informa-tion to FDA regarding medication errors (Id.). The proposed rule generated much comment from indus-try and other stakeholders. As of late 2005, no further action has been taken on the proposed rule, and the existing regulations remain in effect.

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