Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND Posted on May 1, 2014February 11, 2025 by Hannah Faulkner Industry Practices for Expedited Reporting to Investigators Conducting Research Under an IND
Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule Posted on January 30, 2014February 11, 2025 by Hannah Faulkner Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule
Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application Posted on November 7, 2013February 11, 2025 by Hannah Faulkner Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application
Participants’ Perspectives on Safety Monitoring in Clinical Trials Posted on May 3, 2013February 11, 2025 by Hannah Faulkner Participants’ Perspectives on Safety Monitoring in Clinical Trials
Results and Recommendations: New Recommendations from Public-Private Partnership Aim to Improve Clinical Trial Quality and Safety Posted on May 20, 2011February 11, 2025 by Hannah Faulkner Results and Recommendations: New Recommendations from Public-Private Partnership Aim to Improve Clinical Trial Quality and Safety