Regulatory: Page 43

Pharmaceuticals
Examining the Properties of TIJ Fluids and Their Role in Serialization
Editor’s note: Part I of a two-part series addresses issues pertaining to the color fastness of CIJ ink.
April 26, 2018
BK640 ink cartridge.
Regulatory
Laws & Effect: Aiming to Protect Health, FDA Increases Aim at Tobacco
Though a relative newcomer to FDA’s jurisdiction, could its tobacco efforts have more widespread health benefits than drug approval, food safety, and other traditional roles?
April 25, 2018
Eric Greenberg
Pharmaceuticals
A Regulator in an Anti-Regulation Era
Bucking the trend, it appears Scott Gottlieb’s FDA is protecting the public health and trying to make it easier to clear new medicines and devices quickly.
April 24, 2018
Eric F. Greenberg
Pharmaceuticals
CDER Focuses on Drug Safety
Janet Woodcock points to annual ‘Drug Safety Priorities 2017’ report on CDER initiatives, and its efforts to evaluate evolving technologies to protect the public.
April 23, 2018
CDER's Drug Safety Priorities 2017 report.
Nutraceuticals/Dietary
Packaging Protects Products from the Inside-Out
Melbourne-based Swisse Wellness employs a desiccant and a scannable label to protect and authenticate its growing portfolio of products worldwide.
April 20, 2018
Packaging Protects Products from the Inside-Out
Cannabis
First Cannabis-Derived Drug Nears FDA Approval
An advisory panel to the FDA votes in favor of approval of GW Pharma’s Epidiolex. The seizure drug would be the first FDA-approved use of cannabidiol (CBD).
April 19, 2018
Medical marijuana
Medical Device/Packaging
FDA Modernizes Approach to Medical Device Safety and Innovation
New action plan focuses on five key areas, including timely postmarket mitigations, cybersecurity and taking a Total Product Life Cycle approach to device safety.
April 18, 2018
FDA Modernizes Approach to Medical Device Safety and Innovation
Traceability/Serialization
New OIG Report Calls for FDA Education for Pharma Dispensers
In a review of 40 pharmaceutical dispensers, an OIG study shows that most received all drug product tracing details from their trading partners, but more work needs to be done.
April 13, 2018
New OIG Report Calls for FDA Education for Pharma Dispensers
Regulatory
FDA Finalizes Drug Development Process Guidance
Special Protocol Assessment Guidance for Industry aims to bring greater predictability and certainty in new medicine studies to support safety and efficacy.
April 13, 2018
Supply Chain
SpotSee: Connected Recorders
Shock, vibration and temperature indicators increase visibility within the supply chain for the logistics market.
April 12, 2018
SpotBot Cellular
Medical Device/Packaging
FDA Offers Option for 510(k) Clearance
Abbreviated program aims to facilitate evolutionary medical devices to benefit patients. Agency seeks comment on the draft guidance by July 11.
April 11, 2018
FDA Offers Option for 510(k) Clearance
Supply Chain
New ASTM International Standard Supports Hazardous Materials Packaging
A new ASTM International standard helps with pressure testing certain containers that are used to transport hazardous materials.
April 11, 2018
New ASTM International Standard Supports Hazardous Materials Packaging
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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
Cagic industrial sorting and processing machine with control panel and conveyor system
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.
Integrated Water Insoluble Matter Testing Systems
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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