DSCSA

News & Analysis as of

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to...

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”. As the title suggests, the Guidance is part of FDA’s...more

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...more

FDA Issues Draft Guidance for Identification and Notification of Suspect Products

As discussed in our April 11, 2014 Alert, the Drug Supply Chain Security Act (DSCSA) was enacted "to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within...more

3 Results
|
View per page
Page: of 1