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Elaine H. Tseng
Insights 23 results
Client Alert
January 9, 2026
FDA Updates General Wellness and Clinical Decision Support Guidance Documents
Client Alert
December 19, 2025
FDA Issues New Guidance for Enhancing Participation in Drug Clinical Trials
Client Alert
April 4, 2025
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?
Client Alert
January 13, 2025
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)
Client Alert
January 6, 2025
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
Client Alert
July 12, 2024
FDA Issues Updated Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs
Client Alert
July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
Client Alert
July 5, 2024
The LDT Final Rule Goes Into Effect Today
Client Alert
April 30, 2024
LDT Final Rule: Shifting the LDT Battlefield
Client Alert
February 20, 2024
FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials
Client Alert
January 10, 2024
FDA Issues Proposed Rule Classifying Certain Wound Dressings and Liquid Wound Washes For the First Time