Required Submission Documents
- Certified True Copy of valid Certificate of Product Registration (CPR)
- Previously approved insert
- Clinical data supporting the proposed changes or revisions
- Tabulated list of proposed changes with sections tagged and labeled
Restrictions on Indications in Revision Applications
- Applications must not include any new indication not previously approved by the FDA
- Inclusion of such indications, whether advertently or inadvertently, will lead to FDA sanctions
- The indications in the approved insert/labels must exactly reflect those approved in the CPR and application
Clinical Data Requirements
- Any application for product insert revision involving new, additional, or extended indications must be supported by three (3) clinical studies justifying the changes
- Clinical studies are especially required for new dosages and new routes of administration
Approval Requirements for Core Data Sheet and Basic Succinct Statements
- Changes in Core Data Sheet or Basic Succinct Statements must have prior FDA approval before product insert revisions
Post-Approval Compliance Obligations
- Within 30 days from receipt of the approval letter, companies must submit three (3) copies of the approved product insert
- Companies are obliged to ensure that all submissions and supporting documents are complete and orderly to comply strictly with FDA requirements
Legal Consequences
- FDA sanctions will be imposed for non-compliance, including the unauthorized inclusion of unapproved indications
Administrative Authority
- The directive is issued by the FDA under the office of the Acting Director IV, ensuring regulation and compliance with product information updates.