Safety Labeling Changes (SLC)

The FDA’s Drug Safety-related Labeling Changes (SrLC) database provides comprehensive updates to the safety information in FDA-approved prescription drug labeling. These updates include:

• Changes Mandated by the FDA under Section 505(o)(4) of the FD&C Act:
  These are safety-related labeling changes required by the FDA to address new safety information that may affect a drug’s risk-benefit profile.
• Modifications from Labeling and Efficacy Supplement Approvals:
  These are changes resulting from new information submitted by the application holders, such as additional clinical trial data or post-market surveillance findings.

• FDA Notification:
  When the FDA determines that a safety labeling change is necessary, it issues a notification letter to the application holder. This letter outlines the required changes and provides the rationale based on new safety data.
• Application Holder Response:
  Upon receiving the notification, the application holder must respond in one of two ways:
  • Submitting a Labeling Supplement:
    This supplement includes the proposed changes to the drug’s labeling to address the safety concerns identified by the FDA.
  • Submitting a Rebuttal Statement:
    If the application holder believes that the changes are not warranted, they can submit a detailed rebuttal explaining their reasoning, supported by scientific evidence.

• Submission Timeframes:
  The FDA Amendments Act (FDAAA) specifies strict timeframes for the submission of labeling changes. Typically, the application holder must submit the labeling supplement or rebuttal within 30 days of receiving the FDA’s notification.
• FDA Review Timeframes:
  The FDA also has set timeframes for reviewing the submitted labeling supplements or rebuttals. This ensures that the process moves forward promptly, maintaining up-to-date safety information for healthcare providers and patients.

The FDAAA provides the FDA with additional tools to enforce compliance with safety labeling changes, including:

• Post-marketing Requirements (PMRs):
  The FDA can impose PMRs on application holders to conduct further studies or clinical trials to gather additional safety data.
• Penalties for Non-compliance:
  The FDA can impose penalties on application holders who fail to comply with the mandated safety labeling changes within the specified timeframes.

At Masuu Global, we specialize in providing comprehensive Safety Labeling Changes (SLC) services for pharmaceutical companies. Our expertise ensures the safety and compliance of both USFDA-approved Reference Listed and Generic Drugs. Our SLC services are tailored to help companies navigate the complex regulatory landscape, implementing essential labeling changes in response to safety concerns and emerging information.

• Regulatory Guidance:
  We assist in understanding and complying with FDA requirements under Section 505(o)(4) of the FD&C Act and the FDA Amendments Act (FDAAA).
• Notification Response:
  We help prepare and submit labeling supplements or rebuttal statements promptly upon receiving FDA notification letters.
• Timely Implementation:
  We ensure all labeling changes are made within the FDA-specified timeframes, maintaining regulatory compliance.
• Ongoing Support:
  We provide continuous support to address post-marketing requirements and any additional safety data submissions.

With Masuu Global, pharmaceutical companies can confidently manage safety labeling updates, ensuring their products remain safe and compliant with the lawww FDA standards.