June 03, 2021 The following quote is attributed to Donald D. Ashley, J.D., Director of the Office of Compliance for FDA’s Center for Drug Evaluation

GS1 Connect 2021 Digital Edition: Move Beyond Supply Chain Challenges Date: June 8-10, 2021 (Register by June 3, 2021) Website: https://gs1connect.gs1us.org/ Session 701: An Automated

As you know, the FDA recently extended saleable returns verification until 2023. Please join Gateway Checker CEO and Founder Gary Lerner at the HDA 2020

FDA is issuing new guidance for immediate implementation in accordance with 21 CFR 10.115(g)(2). FDA is concerned that large volume of saleable returns coupled with

Friday 9:00 AM – 9:30 AM – Healthcare Theater Conference Track: Healthcare Type: Industry Track Sessions Speaker: Gary Lerner, Managing Director, BrandSure, LLC Description: This

Today FDA issued draft DSCSA compliance guidance on how to identify DSCSA Trading Partners. This draft guidance provides clarity on how to classify trading partner

One Year Enforcement Delay – Not!? Hidden Timetable in DSCSA Product Identifier Requirements With about 100 working days left until the November 27, 2017 deadline

Product Identifier Requirements would take effect no later than November 27, 2018 June 30, 2017 FDA issues a draft DSCSA compliance guidance delaying enforcement action

Understand the Challenges and Opportunities Pharmaceutical traceability is the new regulatory reality. Within the next five years, most markets will mandate pharmaceutical serialization at the

As of January 1, 2015 the DSCSA mandated that all healthcare practitioners who dispense or administer prescription drugs to patients must purchase their prescription drug