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Christina M. Markus (Chris)
Insights 34 results
Client Alert
January 6, 2025
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
Client Alert
July 8, 2024
Finally! FDA Issues Updated Draft Guidance on Diversity Action Plans Mandated by FDORA
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FDA Issues Draft Guidance on Use of Data Monitoring Committees in Clinical Trials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
Client Alert
January 3, 2024
FDA Issues Final Rule Permitting IRB Waiver or Alteration of Informed Consent for Certain Minimal Risk Clinical Investigations
Client Alert
December 21, 2023
FDA Ushers in New Program for Drug Products Manufactured Using Innovative Manufacturing Technologies
Article · Source: Law360
October 23, 2023
How Int'l Regulatory Collabs Can Expedite Pharma Approvals
Client Alert
August 24, 2023
FDA Issues Draft Guidance for Obtaining Postmarket Data on Underrepresented Populations in Drug Clinical Trials
Client Alert
Newsletter
May 22, 2023
Health Headlines – May 22, 2023
Client Alert
May 3, 2023
EUROPE – Revision of EU General Pharmaceutical Legislation
Client Alert
March 7, 2023
FDA Issues Draft Guidance on “External Controls” in Clinical Trials to Support Safety and Efficacy of a Drug