Drug Makers Have Exceeded Expectations In Implementing DSCSA Serialization
Executive Summary
A new barcode assessment study finds the US pharmaceutical industry has come a long way in serializing drug products over the past several years.
You may also be interested in...
Survey Shows Drug Makers Don't Expect To Begin Serializing All Packages By November Deadline
Concerns that the US pharmaceutical industry will not have the necessary serialization systems in place to fully comply with DSCSA product package serialization requirement appear to be bearing fruit, according to a recent survey.
FDA Gives Drug Makers One-Year Reprieve From DSCSA Product Identifier Requirement
FDA will not take enforcement action against pharmaceutical manufacturers that miss this year’s serialization deadline under DSCSA. Enforcement won't begin until a year later. The serialization requirement is the second wave of a three-part system for tracking and tracing pharmaceutical products through the supply chain to thwart drug counterfeiters.
US FDA Urges COVID-19 Transmission Risk Mitigation In Cell And Gene Therapy Manufacturing
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: