Regulatory: Page 34

Pharmaceuticals
Making a Plea for a Single Product Identifier
HDA’s response to FDA’s Draft on DSCSA Product Identifiers notes lack of time to respond. GTIN or NDC identifier, human-readable expiration date format also pose concerns.
December 4, 2018
Making a Plea for a Single Product Identifier
Regulatory
FDA Releases New Guidance for Stored Platelets
Replacing a 2016 guidance, the document includes storage and labeling guidelines as well as reporting instructions for manufacturing and labeling changes.
December 4, 2018
FDA
Pharmaceuticals
New Drug Uses DNA Rather Than Tumor Type to Treat Cancer
The FDA just approved Loxo Oncology’s Vitrakvi drug that treats cancer in an unconventional way.
November 30, 2018
Cancer Cells in a Tray
Packaging/Filling
Mettler Toledo: Safeline X34
X-ray inspection system performs component presence verification and contamination inspection in pharmaceutical products.
November 29, 2018
Mettler Toledo: Safeline X34
Regulatory
FDA Aims to Crack Down on Flavored Tobacco Products
FDA Commissioner Scott Gottlieb released a statement on proposed action to reduce flavored tobacco use among teens.
November 29, 2018
Flavored Tobacco Products
Supply Chain
Shippers Deliver Early-Stage Clinical Trial Samples
Celerion helps its pharmaceutical manufacturer clients safely and swiftly deliver products in environmentally friendly, temperature-sensitive shipping containers.
November 28, 2018
Celerion uses shippers like this to deliver early-state clinical trial samples.
Supply Chain
Reporting Suspicious Orders to the DEA
A DEA Diversion Program Manager highlighted controlled substance order reporting and paperwork to keep on-hand.
November 28, 2018
Dea diversion control
Nutraceuticals/Dietary
FDA Sends Warning Letters Regarding Tianeptine
Two companies receive notifications from agency for selling products marketed as dietary supplements with known safety issues to patients seeking relief from medical conditions such as opioid abuse disorder.
November 20, 2018
FDA Sends Warning Letters Regarding Tianeptine
Medical Device/Packaging
FDA Approves Surgical Augmented Reality
Microsoft’s HoloLens augmented reality system projects 2D, 3D, and 4D images onto a patient’s body to help physicians plan surgery.
November 20, 2018
Medical Augmented Reality
Pharmaceuticals
FDA Cracks Down on StemGenex for a Myriad of Issues
The San Diego-based biologic company was marketing an unapproved stem cell product manufactured in a questionable facility.
November 19, 2018
StemGenex Facility
Regulatory
Tamper Evident Labels Market to Surpass $7 Billion in Next 10 Years
A new Fact.MR Study shows strong growth from the pharmaceutical market, while a ‘high-speed’ market bolsters need.
November 13, 2018
tamper evidence labels market
Robotics/Automation
Fitting Track and Trace into a Patient-First Culture
Catalent’s Bloomington, IN facility meets U.S. and European regulatory deadlines via a turnkey approach on a vial and syringe packaging suite.
November 12, 2018
Catalent’s Bloomington facility serializes and aggregates vials and syringes.
Previous Page
Page 34 of 189
Next Page
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
More Products
In Print
Healthcare Packaging Fall 2026 Healthcare Packaging
Fall 2026 Healthcare Packaging
Healthcare Packaging Spring 2026 Healthcare Packaging
Spring 2026 Healthcare Packaging
Healthcare Packaging Fall 2025 Healthcare Packaging
Fall 2025 Healthcare Packaging
Healthcare Packaging Spring 2025 Healthcare Packaging
Spring 2025 Healthcare Packaging
SubscribeArchives
Downloads
View More »
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
View More »