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FDA REMS Inspections

Objectives:

• Assess the firm’s compliance with the requirements of section 505-1of the Act.

• Assess the firm’s compliance with the requirements detailed in the REMS approval letter.

• Document the firm’s or contractor’s implementation of the REMS.

• Verify the accuracy of the REMS assessment information submitted by the firm to the FDA.

 

Risk Factors

  • REMS with elements to assure safe use (ETASU);

  • REMS with identified issues or violations from a previous REMS inspection;

  • REMS with approved modifications since the last inspection;

  • REMS that have been identified by the Office of New Drugs(OND) or Office of Surveillance and Epidemiology (OSE) with recognized issues;

  • REMS with issues identified during the review of the REMS Assessment Report;

  • REMS that have never been inspected; and

  • REMS not inspected in the last 2-3 years.

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