What is the Purpose of REMS?

Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications Status: Draft Date: September 2009 Target Audience: Industry sponsors and applicants Laws Referenced: Section 505-1 of the Federal Food,...

FDA Submissions Now More Consistent

Providing Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related Submissions using the eCTD Specifications Status: Final Date: October 2005 Organizations: United States Department of Health and Human Services, Food and Drug...