article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law Blog: Biosimilars

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. By Kalie E.

Drugs 59
article thumbnail

Analysis Life Sciences Thank You Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon

Agency IQ

ACRO’s white paper also highlights the potential for “enhanced efficiency, long-term cost savings, and faster collection of data” through risk-based monitoring and other data collection efficiencies.