Regulatory: Page 46

Pharmaceuticals
Peanut Allergy Drug Nears FDA Approval
Aimmune Therapeutics’ treatment consists of repeated exposure to small doses of peanut flour to build up immunity.
March 6, 2018
Peanut Allergy Pill Nears FDA Approval
Medical Device/Packaging
ASTM International Packaging Standard to Aid Medical Devices Industry
To help validate test methods for packaging on medical devices, this new guide aims to help support product quality and safety.
March 5, 2018
ASTM International Packaging Standard to Aid Medical Devices Industry
Traceability/Serialization
FDA: Two New Track and Trace Guidance Docs
The documents are part of FDA’s effort to standardize terms to ensure data is captured and shared in a way that facilitates communication between supply chain partners.
March 5, 2018
FDA
Labeling/Printing
Marchesini Group: Carton Serialization Unit
BL A309 applies a vignette label on the upper panel of a carton; allows users to meet needs related to pharmaceutical traceability.
February 28, 2018
Marchesini Group: Carton Serialization Unit
Traceability/Serialization
TruTag Technologies: SecuriLam Intelligent Laminate
SecuriLam laminate provides supply chain security and traceability for label, document and packaging applications.
February 27, 2018
TruTag Technologies: SecuriLam Intelligent Laminate
Pharmaceuticals
HDA Calls for Universal Suspicious Orders Database
Healthcare Distribution Alliance asks Drug Enforcement Administration to allow state regulators and DEA’s state and local law enforcement partners to access DEA’s database.
February 23, 2018
Pharmaceuticals
Coating Technology Resolves Serialization Issue
Platinum Press works with its suppliers to eliminate a problem customers had experienced with serialized codes rubbing off booklet-style labels.
February 21, 2018
Coating Technology Resolves Serialization Issue
Regulatory
FDA Enforcement Shows Little Change with New Administration
Do the agency’s 2017 enforcement statistics reflect a new anti-regulation philosophy? Not so far, but maybe wait till next year!
February 19, 2018
Eric Greenberg, Legal + Regulatory Columnist
Pharmaceuticals
Adents: Online Demo Platform
For Cloud-based pharmaceutical serialization, this demo tool allows a “test drive” of Level 4 serialization via Adents Prodigi.
February 16, 2018
Adents: Online Demo Platform
Pharmaceuticals
HDA, ValueCentric Announce API Certification for Origin
Origin is a source of GTIN reference data for the pharmaceutical industry. Adents represents the first partner to go through the certification process.
February 16, 2018
HDA, ValueCentric Announce API Certification for Origin
Inspection
METTLER TOLEDO PCE: Labeling/Verification System
T2620 helps pharmaceutical companies meet the requirements of global serialization regulations/Falsified Medicines Directive.
February 15, 2018
METTLER TOLEDO PCE: Labeling/Verification System
Regulatory
FDA's Draft Guidance on Label Highlights Section
The new guidance includes content and formatting information, and acknowledges where carton and container labels may differ from the Highlights. Comments are due March 20.
February 14, 2018
FDA Labeling Guidance
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Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
Manufacturers who treat ISO 11607's worst-case clauses as a risk-management tool, rather than a box to check, are far better positioned to keep their packaging, and their products, performing as intended.
Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Technician in hairnet and blue shirt working at industrial machinery in laboratory setting
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Worker holding tablet displaying supply room inventory dashboard with charts in front of blue storage bins
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
3D printer setup with supply bottles and industrial equipment on red platform
Package Development
Designing the Convenience of Tamper Evidence
Products
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AI-enabled X-ray Inspection Software Platform
At PACK EXPO, Eagle launches SimulTask 6, which offers food processors advanced image analysis, real-time production monitoring, automated reporting, and task-based inspection.
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Induction Sealing Gap System
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Robotics/Automation
Market Snapshot: Life Sciences Manufacturing
Pharmaceutical manufacturing assembly line with blue and white vaccine storage boxes and vials on conveyor system
Robotics/Automation
Automation Success on the Line
Healthcare professionals discussing pharmaceutical technology with medical storage equipment and digital analytics interface displayed
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Elderberry & Honey Tonic bottle surrounded by dried flowers in white bowl on grass
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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