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Christina M. Markus (Chris)
Insights 22 results
Client Alert
June 30, 2026
FDA Signals Greater Flexibility for Single-Trial Drug Approvals
Article · Source: Journal of Health Care Compliance
May 1, 2026
HHS-OIG Issues Guidance on Pharma DTC Prescription Drug Sales, but Key Legal Questions Remain
Client Alert
April 20, 2026
FDA Reminds Sponsors and Researchers to Disclose Clinical Trial Results to ClinicalTrials.gov
Client Alert
February 16, 2026
FDA Issues Refuse-to-File Letter for mRNA-based Vaccine BLA
Client Alert
February 2, 2026
HHS-OIG Issues Guidance on Pharma DTC Prescription Drug Sales, but Key Legal Questions Remain
Client Alert
December 29, 2025
Medicare and Medicaid Demos Seek to Impose MFN Pricing: An Overview of GENEROUS, GLOBE, and GUARD
Client Alert
December 19, 2025
FDA Issues New Guidance for Enhancing Participation in Drug Clinical Trials
Article · Source: Thomson Reuters Westlaw Today
November 20, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
Client Alert
November 19, 2025
FDA Leaders Propose New “Plausible Mechanism Pathway” for Development and Approval of Drugs and Biologics
Client Alert
September 11, 2025
Advancing Novel Treatments for Rare Diseases: FDA Unveils and Previews New Efforts to Assess Therapies for Very Small Patient Populations
Client Alert
July 11, 2025
FDA Publishes More Than 200 Complete Response Letters (CRLs) With More to Come
Client Alert
May 9, 2025
New Executive Order Promotes Domestic Production of Critical Medicines