GS1 US Publishes New DSCSA VRS Implementation Guide
GS1 US’s new DSCSA VRS Implementation Guide, a new resource for anyone making use of the verification router service for DSCSA compliance.
Search Results for: "enforcement discretion"
DSCSA Schedule Assessment, July 2019
It’s time to assess the progress of the industry and the FDA in their quest toward the November 27, 2023 Drug Supply Chain Security Act (DSCSA) goal known as the Enhanced Drug Distribution (EDDS) phase…otherwise known as just ‘2023’ (see “EDDS: The New Data Exchange Requirements”). Let’s step back and look at where we have … Continue reading DSCSA Schedule Assessment, July 2019
Is The FDA About To Delay Enforcement Of The Wholesaler’s 2019 Mandate?
Could the FDA delay enforcement of the wholesaler’s 2019 DSCSA requirements?
DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations
As I mentioned last week, the FDA published two new draft DSCSA guidance documents on the day of the recent FDA DSCSA Public Meeting (see “FDA DSCSA Public Meeting #3: A Difference?”). Let’s take a closer look at what’s in them and their significance to companies facing the Drug Supply Chain Security Act (DSCSA). I’ll … Continue reading DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations
DSCSA Cascading Delays
What happens to the serialization delay as the affected product moves down the supply chain?
FDA Tea Leaves: Are They About To Delay The November Deadline?
Is the FDA about to delay the DSCSA serialization deadline? The odds are increasing that they will…and soon. Read why in this insightful essay!
Will Manufacturers Have Trouble Verifying Some Drugs Next Year?
PDSA fears the potential inability of some manufacturers to verify, in the DSCSA sense, certain drugs between now and November of 2019.
FDA DSCSA Deadline Passes Quietly
Last Friday was the deadline for the FDA to publish four new guidance documents under the Drug Supply Chain Security Act (DSCSA) (see “Decoding The FDA’s DSCSA Timeline”). The deadline was established by the U.S. Congress when they enacted the legislation and it was signed by President Obama on November 27, 2013 (see “It’s Official, … Continue reading FDA DSCSA Deadline Passes Quietly
