Emergency Use Authorization of Medical Products - Clinical Submission

The Emergency Use Authorization (EUA) authority recently granted by Congress under Section 564 of the FD&C Act 21 USC 360bbb-3, permits the FDA/FDA Commissioner to authorize the use of an unapproved medical product or an unapproved use of an approved medical product under emergent situations. Under Section 564, the FDA Commissioner may allow emergency medical measures to diagnose, treat and prevent serious or life-threatening diseases or conditions caused by agents, when there are no adequate, approved and available alternatives. The FDA Commissioner, on a case by case basis, will seek advice from DoD, EUWG, ASPR, CDC, NIH, DHS, DVA and other Federal agencies as needed and appropriate.

Clinical Submission Format and Content - Section 564

• paper or electronic
• when paper, FDA recommends that a minimum of 3 copies be provided
• table of contents
• application for authorization may refer to previously submitted data and documentation to FDA
• reviewable form
• risk/benefit statement
• well-organized clinical study reports
• proof of safety and effectiveness
• well-organized nonclinical study reports
• well-organized complete assessments
• well-organized analyses
• well-substantiated interpretations of clinical and nonclinical safety and efficacy findings
• other relevant data and documentation
• clinical source data
• nonclinical laboratory data
• other relevant animal studies
• clinical case report tabulations
• clinical case report forms
• clinical withdrawals
• therapeutic failures
• lost to follow-up data
• adverse event information
• all patients who died during study
• supporting published literature
• supporting references
• certified translations of data and documentation.

Data quality is critical and a must. GCP, GLP, GMP and QC/QA statements, SOPs and plans must accompany the clinical submission. Well-controlled data and documentation will facilitate FDA review and authorization. Quality management of data, documentation, processes, procedures and systems is a must.

A quality controlled discussion of Risks and Benefits must include measures taken to mitigate risk and optimize benefit, document uncertainly and limitations, identify data gaps and provide contraindications.

QC, QC, and QC again, data and documentation to ensure accuracy and consistency with current and previously submitted FDA and other regulatory agency clinical submissions.