Regulatory: Page 39

Regulatory
J&J to Pay Record Amount in Talcum Powder Suit
A Missouri jury ordered Johnson & Johnson to pay out billions to women claiming their talc-based products contained asbestos and caused cancer.
July 27, 2018
J&J Baby Powder
Pharmaceuticals
Contamination Prompts Voluntary Valsartan Recall
Manufacturing changes at China facility believed to be the source of the NDMA impurity—an issue that could trace back to 2012.
July 26, 2018
Contamination Prompts Voluntary Valsartan Recall
Pharmaceuticals
FDA Looks to End Patent Games to Lower Drug Prices
FDA Commissioner Scott Gottlieb has a plan to boost the biosimilar market and drive prices down by putting an end to patent “gaming.”
July 24, 2018
FDA Commissioner Gottlieb
Cannabis
FDA on Marijuana-based Drug Approvals: Not So Fast
The agency says don’t get ahead of yourself if you want FDA to clear your new drugs made of cannabis; settle down and take your bureaucratic medicine.
July 23, 2018
Eric Greenberg
Supply Chain
Drug Importation in Times of Need
The HHS announced a work group to evaluate policies for importing certain drugs in short supply domestically. But one industry group has supply chain security concerns.
July 23, 2018
blister packs
Regulatory
Innovations Helping to Grow the Clinical Trial Packaging Market
Due to rising number of discoveries of new drugs in research laboratories around the world, the global clinical trial packaging market is receiving a considerable lift, with the bottle segment leading the way.
July 19, 2018
Innovations Helping to Grow the Clinical Trial Packaging Market
Regulatory
CPSC Seeks Comment on Improving Recall Effectiveness
The Consumer Product Safety Commission is soliciting info on recall marketing, challenges, technologies, security and more. Comments are due by Sep 5, 2018.
July 18, 2018
serialization barcodes
Regulatory
And Now, Warning Letter Spam
FDA says, ‘Hey! I’m warning you: I’m not warning you!’
July 16, 2018
Regulatory
Aseptic Processing Woes for CMO in China
The producer of sterile injectables and APIs was hit with an FDA warning letter, citing issues with aseptic processing and data integrity.
July 12, 2018
FDA
Traceability/Serialization
TraceLink: Product Information Manager
Standards-based network application for its digital information sharing platform addresses a range of use cases, beginning with saleable returns.
July 11, 2018
TraceLink: Product Information Manager
Regulatory
What If FDA Didn’t Pre-Approve Products At All?
Today, we noodle, just for fun, on what might happen if radical changes were made in FDA’s powers over drugs and devices.
July 11, 2018
Pharmaceuticals
FDA Takes More Active Role Regarding DSCSA
The agency, as well as the Healthcare Distribution Alliance and GS1 US, provide educational guidance for the pharmaceutical industry, notes RxTrace’s Dirk Rodgers.
July 10, 2018
FDA Takes More Active Role Regarding DSCSA
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Top Stories
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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Laboratory technician in sterile protective gear holding a clear glass vial for sample analysis
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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