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Regulatory: Page 12
Regulatory
Rare Disease Patient and Advocate Talk Actions You Can Take
“We don't believe patients should have to start their own drug company to save themselves or save their child,” says Julia Jenkins, policy expert, at the PDA Annual Meeting.
April 3, 2023
Regulatory
FDA Issues Guidance for Cybersecurity of Medical Devices RTA Policy
FDA
The document addresses the Consolidated Appropriations Act, 2023, Ensuring Cybersecurity of Medical Devices section’s refuse to accept policy for cyber devices and related systems.
April 2, 2023
Regulatory
FDA Issues Guidances for Medical Device Transition Plans
FDA
The agency has issued the documents to assist with transition plans for COVID-19-related medical devices.
March 28, 2023
Nutraceuticals/Dietary
Jones Healthcare Set to Help Nutraceutical Brands Meet New Canadian Regulations
Jones Healthcare Group
The company’s investment in a Gallus Labelmaster 440 label press from Heidelberg supports Canada’s extended content requirements.
March 22, 2023
Traceability/Serialization
Antares Vision Group Partnering With Renown Health Network
Antares Vision Group
rfxcel, part of Antares Vision Group, will implement DSCSA compliance solutions to help ensure pharmacies across the northern Nevada healthcare network comply with the regulations.
March 16, 2023
Traceability/Serialization
Confusion Persists Surrounding Suspect and Illegitimate Product
Under DSCSA, some manufacturers and distributors are struggling to understand which situations require a 3911 notification.
March 13, 2023
Regulatory
FDA Publishes Final Continuous Manufacturing Guidance
FDA
The Continuous Manufacturing of Drug Substances and Drug Products guidance represents proactive steps the FDA is taking to facilitate the pharmaceutical industry’s adoption of advanced manufacturing technologies.
March 7, 2023
Traceability/Serialization
Op-ed: Data Issues Abound as DSCSA Deadline Nears
Trading partners are working diligently to connect data systems in compliance with the Drug Supply Chain Security Act (DSCSA). But significant challenges remain ahead of the November finish line.
February 22, 2023
Industry News
Working Group Formed to Improve Medical Device Quality, Supply Chain
MedAccred
The new working group was inspired by the FDA Center for Devices and Radiological Health’s Case for Quality Initiative, which seeks to collaboratively advance the quality, safety, and effectiveness of medical devices.
February 16, 2023
Cannabis
FDA Issues Final Guidance on Human Drugs Containing Cannabis
FDA
The agency’s ‘‘Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research’’ document finalizes the draft guidance issued in 2020.
February 1, 2023
Packaging/Filling
Pharmapack Experts Predict Future of European Packaging Companies
Pharmapack Europe
Many smaller and medium-sized European packaging companies will have to grow or face being acquired in 2023, according to Pharmapack Europe experts.
January 26, 2023
Medical Device/Packaging
Roundtable Ahead of Pharmapack Europe Talks Drug Delivery Trends
From patient-centricity in a connected world to holistic sustainability strategies and proposed MDR amendments, hear what consultants have to say about the changing medical device landscape in 2023.
January 20, 2023
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Top Stories
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.
Pharmaceuticals
Are Bacteria Cellulose Face Masks the Future of Skin Health?
Packaging/Filling
How an Integrated Leaflet Simplifies Pharmaceutical Cartoning
Package Design
What Autonomous Supply Rooms Mean for Healthcare Packaging
Package Development
Designing the Convenience of Tamper Evidence
Products
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
Robotics/Automation
Automation Success on the Line
Labeling/Printing
Beyond the Label: Rethinking Healthcare Packaging
Package Design
Package Design Ideas Transforming Wellness, OTC, and Healthcare Brands
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