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Jun 25, 2007
 |  BioCentury  |  Politics, Policy & Law

Reconciliation points

Reconciliation points

PDUFA, drug safety legislation passed by House Energy & Commerce FDA Revitalization Act (FDARA) passed by the Senate
Risk evaluation and mitigation strategy (REMS) • FDA can require a REMS if it "is necessary to ensure that the benefits of the drug involved outweigh the risks of the drug." • FDA can require a REMS if there is "a signal of a serious risk with the drug."
• Only mandatory element is a timetable for assessments • REMS must include labeling and a timetable for assessments
• REMS can include a Med Guide and/or product insert; a risk communication plan; restrictions on distribution or use • REMS can include a Med Guide and/or product insert; requirements for post-approval studies or clinical trials; a risk communication plan; a requirement to submit all advertisements to FDA for preview; and restrictions on distribution or use
• REMS reviewed...

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