Law Summary

Introduction

This FDA Circular outlines the requirements and procedures for pharmaceutical companies seeking to revise or update various informational materials related to their products, including package inserts and prescribing information.

Application Requirements

Pharmaceutical companies must submit the following documents when applying for revisions or updates:

• Certified True Copy of valid Certificate of Product Registration (CPR)
• Previously approved insert
• Clinical data that justifies the proposed changes or revisions
• Tabulated list of proposed changes that must be tagged and labeled accordingly.

Prohibition of Unapproved Indications

Any application that includes indications not previously approved by the FDA will be subject to appropriate sanctions. This provision is aimed at preventing unapproved information from being disseminated, which could lead to misinformation regarding product usage.

• Key Definitions:
  • Indication: A specific use or condition for which a drug is approved.

Submission of Clinical Studies

For applications pertaining to new, additional, or extended indications, applicants must provide:

• Three (3) clinical studies to justify the proposed changes, particularly regarding new dosages and routes of administration.

Core Data Sheet and Basic Succinct Statement

Changes to the Core Data Sheet or Basic Succinct Statement must receive prior approval from the FDA before any product insert revisions can be made.

Post-Approval Submission Requirements

After receiving approval for revisions, companies are required to:

• Submit three (3) copies of the approved product insert within 30 days of receipt of the approval letter.

Compliance Obligations

All companies are mandated to ensure that their submissions and supporting documents are complete and comply with the outlined requirements. Non-compliance may lead to regulatory actions.

Sanctions for Non-Compliance

• Applications that inadvertently or advertently include unapproved indications may incur appropriate FDA sanctions, emphasizing the importance of adherence to the application process.

Key Takeaways

• Pharmaceutical companies must provide valid documentation and clinical justification for any changes to product information.
• Unapproved indications will lead to regulatory penalties.
• Prior FDA approval is necessary for modifications to both the Core Data Sheet and Basic Succinct Statement.
• A strict timeline of 30 days is imposed for submitting approved inserts post-approval.

This circular serves as a crucial guideline for ensuring that pharmaceutical companies maintain compliance with FDA regulations regarding product information revisions.