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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