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Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association between the product and a safety signal is present. The rule also provides clarification as to what the Agency considers to be new information to be incorporated into a label change. Specifically, new information "must reveal risks of a different type or greater severity or frequency than previously included in submissions" and includes meta-analyses, the new regulation states." FDA requires that drug, biologics, and medical device manufacturers obtain FDA approval of their warning labels before the drugs or devices are marketed and sold. Manufacturers generally must also obtain FDA approval before making changes to labeling information. However, in limited circumstances, companies can revise or supplement their warning labels prior to FDA approval (through changes being effected (CBE) supplements) to ensure consumers are immediately made aware of newly discovered risks.
The labeling regulations, which became effective in late September 2008, clarify that a manufacturer can make unilateral pre-FDA approved labeling changes "only to reflect newly acquired information" when there is "reasonable evidence of a causal association" between the drug or device and the risk. The final rule defines "newly acquired information" as "information not previously submitted to [the] FDA." This includes “new analyses of previously submitted data," such as adverse event reports, new clinical study information, and new analyses that “reveal risks of a different type or greater severity or frequency than previously included in submissions to [the] FDA.
Areas Covered in the Session:
- Understand the definition of "newly acquired information" than previously included in submissions to FDA
- Learn why the January 2008 proposal suggested the "newly acquired information" referred only to data derived from reports of adverse events
- Proposed rule may play a part in the U.S. Supreme Court consideration of the preemption issue
- Understand the background and history with the labeling changes
- Define how this impacts the manufacturer and modifications to label changes
- Learn why a CBE supplement is available only if there is "sufficient evidence of a causal association"
- Final rule clarifies the FDA's pre-existing view of when a CBE supplement is appropriate
- Understand FDA's objective of the final rule and review several industry comments
Who Will Benefit: This webinar will provide valuable assistance and guidance to device companies in involved in labeling changes. The employees who will benefit include:
- All levels of Management for all departments and those who desire a better understanding or a "refresh" overview
- QA/QC
- Regulatory Affairs and Compliance
- Marketing & Sales
- Engineering/Technical Services/Operations
- Consultants