Medical Information
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
Medical Information
What is the Drug Supply Chain Security Act (DSCSA)?
Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....
Clinical Research Solutions
FDA Issues Two Draft Guidances Related to the Drug Supply Chain Security Act
FDA is announcing the availability of two guidances to help trading partners comply with the Drug Supply Chain Security Act (DSCSA). These documents are critical steps toward implementing the DSCSA...
Clinical Research Solutions
FDA Gains Ground in Development of Pilot Program Required Under Drug Supply Chain Security Act
The Drug Supply Chain Security Act (DSCSA), which was signed into law in November 2013, “outlines critical steps to build an electronic, interoperable system” to identify and trace prescription drugs...