Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Industry Needs To Be Aware of Serialization Challenges Under DSCSA

Executive Summary

US pharmaceutical industry is warned that products “will not flow through the supply chain if the digital data is not right” under DSCSA, says official. Law’s second phase, which takes effect in November, mandates first-ever digital serialization requirements to ward off drug counterfeiting.

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.

FDA Officials Cite Reasons For Denying Application Reviews Over Data Integrity Breaches

Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.

Topics

Related Companies

UsernamePublicRestriction

Register

MT142313

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel