Revised Labeling Review for Orfadin Documentation

To submit this form, please send it via email to the designated regulatory office. You can also opt for fax submission to the provided number for immediate processing. If preferred, submit through the official online submission portal or by mailing a physical copy to the relevant address.

Key dates regarding the Orfadin labeling review include April 20, 2016, the date of the memorandum. Future submissions for further reviews may be required as per FDA regulations. Always check for updates as new guidelines may emerge.

The purpose of this form is to ensure accurate and safe labeling for the medication Orfadin. It serves as a comprehensive review to mitigate any potential medication errors. Proper labeling is crucial for patient safety and regulatory compliance.

• 1. Application Number: The unique identifier for the NDA application.
• 2. Product Name: The name of the medication being reviewed.
• 3. Submission Date: The date when the label revisions were submitted.
• 4. Reviewer Information: Details about the primary and leading reviewers.
• 5. Conclusion: Final assessment regarding the changes made to the labels.

Failure to submit this form can result in non-compliance with FDA regulations. It may lead to potential delays in product availability or issues in dispensing the medication correctly.

• Regulatory Delays: Inability to bring the medication to market timely.
• Patient Safety Risks: Potential for medication errors due to unclear labeling.
• Legal Compliance Issues: Violation of FDA requirements can result in penalties.

• 1. Label Revisions: When updates to drug labeling are needed based on recommendations.
• 2. Regulatory Submissions: For formal submission to the FDA regarding product changes.
• 3. Safety Assessments: To evaluate the labeling from a risk management perspective.