Clinical Research FDA Pharmacy White Paper 
FDA Law Blog: Biosimilars
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.
Agency IQ
APRIL 12, 2024
These efforts allowed many trials to retain existing trial enrollees, though it did often require modifications to be made to trial protocols at the urging of both the FDA and European Medicines Agency. FDA’s work on DCTs and DHTs – and more The FDA released its first, long-awaited draft guidance on conduct of DCTs in May 2023.
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