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.
https://www.youtube.com/watch?v=RIDKSBsLqx4
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.
https://www.youtube.com/watch?v=RIDKSBsLqx4
