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1,882 Results
Section: Industry News > Regulatory
Traceability/Serialization
HDA Survey Offers Some Troubling DSCSA Prep Results
With just two years left to meet the Nov. 2023 DSCSA requirements, a readiness survey shows that there is much work to be done in drug supply chain traceability. 57% of manufacturers surveyed have no successful data connections in production environments.
September 16, 2021
Regulatory
Four DSCSA Guidances Were Released this Summer: Are You Up to Date?
Read what’s new on DSCSA regarding suspect and illegitimate product, product identifiers, and enhanced drug distribution security at the package level.
August 27, 2021
Cannabis
Importing Cannabis Packaging? Make Sure Your Packaging Suppliers Know the Industry
From the Cannabis Packaging Conference West in Anaheim: With U.S. Customs and Border Protection on the hunt for what they deem to be 'paraphernalia,' packaging suppliers must be aware of nuance in describing what products are coming into the country.
August 13, 2021
Regulatory
Fresenius Kabi Goes Above and Beyond DSCSA Requirements
With the support and standards of GS1 US, the pharmaceutical manufacturer fulfills customer needs for an additional system to ensure safe use of medication on a unit-of-use level.
August 12, 2021
Medical Device/Packaging
Manufacturers To Highlight Medaccred Accreditation At Medical Design And Manufacturing (West) 2021
August 11, 2021
Regulatory
FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)
FDA
The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.
July 10, 2021
Regulatory
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
FDA
Guidance for industry and FDA staff. Comments can be submitted.
May 21, 2021
Traceability/Serialization
Pharma Supply Chain: Master Data Exchange in 2021
The exchange of data needs to move from today’s manual processes to automated operations. Experts recap current progress, challenges, and what a “happy path” looks like.
May 20, 2021
Cannabis
One Step Closer to Cannabis Access for Medical Research
After years of dragging their heels on approving marijuana cultivation applications for research, the DEA looks to be moving forward with licenses soon.
May 18, 2021
Cannabis
Smudge-Proof Cannabis Batch Labels Offer Colorful Compliance
High Desert Pure employs on-demand printing for up-to-the-minute compliance and traceability information for its nearly 30 SKUs.
May 6, 2021
Inspection
Expedite Med Device Approval with FDA’s New Program
Medical device manufacturers can potentially speed review by testing to recognized standards performed at a list of FDA-accredited labs released in April 2021. Watch this Take Five video to learn more.
April 30, 2021
Packaging/Filling
2021 PDA Annual Meeting: Trend Roundup
The Parenteral Drug Association (PDA) virtual conference offered plenty of new perspectives in aseptic filling, flexible facilities, and more.
April 28, 2021
Materials
ASTM International Honors PAXXUS CEO with Award of Merit
PAXXUS
Dhuanne Dodrill, CEO of PAXXUS, has been honored by ASTM International for her efforts in medical packaging.
April 19, 2021
Regulatory
Pre-Fabricated POD for Filling? Don’t Overlook One Key Topic | Modular: The Modern Way of Manufacturing Injectables
If you’re implementing a pre-fabricated POD at your facility, this Take Five video answers why you can’t overlook space for support systems. Also covered: As injectables increase, they become more customized, requiring modular, future-proof equipment.
April 16, 2021
Regulatory
Demystifying FDA’s ASCA on Biocompatibility for Expedited Review
Live from MD&M BIOMEDigital: Medical device manufacturers can potentially speed review by testing to recognized standards performed at accredited labs.
April 7, 2021
Cannabis
CANnabis or CAN’Tabis: Where is Cannabis Heading Amid New Administration?
Listen in as Healthcare Packaging's director of editorial content talks new directions for cannabis regulation, packaging updates, consumer behavior, and more.
April 6, 2021
Inspection
5 Tips To Improve Your Remote/Hybrid Audits
Whether you’re a manufacturer or contract organization, audits are a key part of ensuring quality. Don’t overlook these tips from our "Take Five with HCP" video when switching from in-person supplier audits to virtual or hybrid audits in the pandemic.
April 2, 2021
Market Trends
PDA’s 2021 Honor Awards
The Parenteral Drug Association (PDA)
Honorees include those who work in packaging science, automated visual inspection, and more.
March 24, 2021
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