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With a Drug Supply Chain Security Act deadline looming, FDA published its final guidance clarifying terms the agency uses to describe illegitimate...
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug...
Last week, the FDA authorized the booster doses for both the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines and mix and match booster doses. The FDA also proposed a new rule for...
This week, the Department of Health and Human Services announced $100 million in American Rescue Plan funding for state programs supporting primary health care workers in underserved communities.
Navigating DSCSA Implementation: Key Requirements & 4 New FDA Guidances By Madeleine Giaquinto, Manager of Regulatory Affairs, Greenleaf Health, Inc. In its seventh year of implementation, trading partners involved in manufacturing, distributing, and dispensing prescription drugs in the U.S. (Industry) continue to grapple with requirements of the Drug Supply Chain Security Act (DSCSA), working to set up a fully interoperable electronic system for securing and tracing products across Industry sectors by November 2023. The goal of the DSCSA is to produce a system that enhances national pharmace...