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Regulatory: Page 23

Regulatory
Med Devices and the FDA: Extended Deadline, Worker Safety
In extending UDI compliance dates for low-risk products, FDA cited challenges related to COVID-19. CDRH also issued recommendations for personnel safety in med device manufacturing.
July 17, 2020
Udi
Regulatory
New FDA Insight Podcast on Emerging Topics
First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.
June 24, 2020
FDA Commissioner Dr. Stephen Hahn
Traceability/Serialization
3 EPCIS Data Exchange Issues in Pharma Traceability
Conformance testing services have emerged to cut down on wasted back-and-forth between manufacturers and trading partners to get efficient data exchange up and running.
June 16, 2020
Gary Lerner, president at Gateway Checker Corporation, presented at GS1 Connect.
Supply Chain
States Focus Legislation on Prescription Drug Costs
Though attention has turned to COVID-19, state legislatures were already pivoting away from last year’s opioid legislation to address drug pricesβ€”an issue that requires the Healthcare Distribution Alliance to engage across all 50 states.
May 14, 2020
Getty Images 1127958533 Drug Prices
Traceability/Serialization
DSCSA and COVID-19
How is the pandemic response impacting the complex and evolving national traceability goals for pharmaceuticals?
May 12, 2020
Getty Images 1022854424
Supply Chain
HDA: The Need for Distributor-Pharmacy Partnership During Pandemic
Healthcare Distribution Alliance is seeking to provide β€œa greater understanding of how distributors are working each day” to meet inventory needs for supply chain partners and patients.
April 28, 2020
Ambient Distribution Getty Images 984835220
Regulatory
FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection
FDA
Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.
April 28, 2020
Fda Stock Photo
Cannabis
Cannabis Relief Bill Introduced in House
β€œThis critical legislation would allow legal cannabis businesses to access disaster relief loans and other programs available during the COVID-19 crisis,” NCIA Executive Director.
April 24, 2020
Getty Images 581032315
Aseptic/Sterile
Aptar Requests U.S. FDA Emergency Use Authorization for N95 Filtering Facepiece Respirator Decontamination with ActivShield(TM)
Aptar
The company is working to provide approximately four million ActivShield strips per week and is working to expand its production capacity with the intent to deliver ten million per week by the end of April.
April 17, 2020
N95 Mask Decontamination with ActivShield(TM) by Aptar
Machinery
Take PDA's COVID-19 Survey in Pharmaceuticals
PDA
The Parenteral Drug Association (PDA) is conducting an important assessment to understand industry impacts on operations and supply chains.
April 6, 2020
Getty Images 116406615
Logistics & cold chain packaging
PPE and Device Manufacturers: FDA Offers Import Instructions
To increase U.S. supplies, FDA is providing instructions and a specific email address to get questions and concerns addressed quickly.
March 24, 2020
Gettyimages 107907121 2
Regulatory
Honeywell Collaborates With AI Specialist Bigfinite to Speed Medical Therapies
The collaboration will focus on helping biotech and pharma industries understand and make use of artificial intelligence and machine learning to enable faster development.
February 10, 2020
Honeywell Bigfinite Collaboration 300 Dpi
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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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