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1,882 Results
Section: Industry News > Regulatory
Regulatory
The Impact of the Chevron Deference in Pharmaceutical Packaging
The Chevron Deference has recently been overturned, resulting in potentially less bureaucratic control over regulated industries, such as the FDA.
July 30, 2024
Traceability/Serialization
Cosmeceuticals Co. Completes First Phase of Serialization
Episciences, Inc.'s new track & trace system offers enhanced supply chain visibility while deterring gray market diversion for its popular skin care products. With more than several dozen unique offerings, initiating new SKUs has proven a smooth process.
June 12, 2024
Recyclability
Upcoming SPMC Paper to Educate Lawmakers on Sterile Packaging
“We want to highlight the critical role that sterilization packaging plays … and share the potential risks and unintended consequences that could be caused by, in essence, ill-suited policy or legislation," says Nick Packet.
May 31, 2024
Traceability/Serialization
RFID Product Tracing Through the Point of Care
CCL Healthcare
Hospitals, pharmacies, and patients can access product data—including authentication, recalls, and expiration—with a simple RFID scan or smartphone tap via smart labels from CCL Healthcare’s eAgile.
April 10, 2024
Temp Control/Cold Chain
ANSI/PDA Standard on Cryopreservation of Cells for Cell and Gene Therapies Receives Complete Recognition Status by U.S. FDA CBER
The Parenteral Drug Association (PDA)
The 2021 standard is included in a cohort of standards relevant to regenerative medicine therapies recognized either completely or partially by the Center for Biologics in 2023.
April 4, 2024
Traceability/Serialization
Finding the Right DSCSA Contact Remains a Challenge
Live from HDA's Distribution Management Conference: Echoing 2023 concerns, state boards of pharmacy discuss why reaching the right contact in a timely matter is so critical.
March 12, 2024
Supply Chain
HDA Issues Policy Platform Addressing Drug Shortages
Healthcare Distribution Alliance (HDA)
March 4, 2024
Regulatory
PFAS: Navigating Materials of Concern in Life Science Packaging
From regulations to supplier inventory, how might PFAS bans impact your operations in the short- and long-term? What might be the next materials of concern?
January 23, 2024
Pharmaceuticals
Consumer Risk Increases from Growth in Online Pharmacy Buying
A new survey reveals 60% of online pharmacy users would consider purchasing from an unapproved source for convenience, and 47% of Americans falsely believe that only safe, verified websites selling prescription drugs appear at the top of search results.
January 11, 2024
Market Trends
Top 10 Packaging and Labeling Quick Hits of 2023
News bits from around the world in packaging, labeling, and drug delivery.
January 5, 2024
Quick Hits
Contamination Issue Leads to Pain Reliever Spray Recall
In the affected lot, a low level of benzene came from the propellant in the can.
January 3, 2024
Traceability/Serialization
Top 10 of 2023 - #3: Op-ed: Data Issues Abound as DSCSA Deadline Nears
Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #3 is an HDA op-ed detailing the significant challenges that remain ahead of the November finish line to connect data systems in compliance with the DSCSA.
January 2, 2024
Traceability/Serialization
Top 10 of 2023 - #5: What Does a DSCSA Stabilization Period Mean?
Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #5, FDA announced a DSCSA stabilization period through Nov. 2024 but is urging all trading partners not to take their feet off the gas.
December 29, 2023
Temp Control/Cold Chain
Top 10 of 2023 - #7: Merck Expert Shares 5 Tips for Qualifying Pallet-Sized Thermal Shippers
Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #7, find out why Lee Menszak advocates for shipper-to-shipper variability testing from his talk at ISTA’s TempPack event.
December 27, 2023
Traceability/Serialization
Top 10 of 2023 - #9: Fresenius Kabi Infuses Safety with Unit-of-Use 2D Barcodes
Join us as we look back at the most-read Healthcare Packaging stories of 2023. At #9, the Germany-based company enhances efficiency and patient care through innovative labeling solutions.
December 23, 2023
Regulatory
Syntegon Podcast Covers Pharma Topics From a Machine-Builder Point of View
Syntegon
On Syntegon’s new podcast series “Machines & Medicine,” pharmaceutical manufacturing experts discuss complex issues in the industry, which faces regulations like no other.
December 14, 2023
Regulatory
Preparing For Your Next FDA Inspection
Your checklist to ensure a passing grade.
November 28, 2023
Regulatory
FDA Issues Draft Guidance for Biosimilar Products Labeling
The guidance explains what relevant data and information from the reference product labeling should be incorporated into biosimilar and interchangeable biosimilar product labeling.
November 10, 2023
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