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Regulatory: Page 15
Regulatory
FDA Finalizes Instructions for Use Guidance
U.S. Food and Drug Administration
The document clarifies IFU labeling for pharmaceutical manufacturers to help consumers understand complicated instructions when using a drug or biologic.
August 2, 2022
Regulatory
FDA Releases Draft Guidance on Use of Remote Regulatory Assessments
The guidance covers voluntary and statutorily authorized RRAs, but does not change the core requirements of inspections and pre- and post-market authorities.
July 26, 2022
Traceability/Serialization
UDI Implementation Highlights Global Challenges
Q&A: At times, the hardest parts of UDI implementation are not about data matrices and linear barcodes at all. Jay Crowley talks global databases, portfolio management, and workforce issues.
July 25, 2022
Supply Chain
HDA Traceability Seminar in D.C. PLUS Webinar Series
Healthcare Distribution Alliance (HDA)
HDA will hold a webinar series (August 11 and 25 and September 15 and 29) prior to the in-person Traceability Seminar taking place October 12 to 14 in Washington D.C. Sessions will cover DSCSA, EPCIS, wholesale distributor services, VRS, and more.
July 22, 2022
Medical Device/Packaging
Fundamentals of Medical Device Packaging: In-Person Course Oct. 2022
The course, developed through IoPP’s Medical Device Packaging Technical Committee, takes place at McCormick Place at PACK EXPO International in Chicago (class dates: Oct 24-26) in three half-day sessions, totaling 13.5 hours.
July 22, 2022
Regulatory
FDA Holding Webinar on Animal Drug Manufacturing System eSubmitter Tool
U.S. Food & Drug Administration
The session will provide information about new enhancements to the system used to support the creation of electronic, secure submissions to the FDA’s Center for Veterinary Medicine for review.
June 20, 2022
Regulatory
FDA Issues Radiation Sterilization Update for PMA Holders
U.S. Food & Drug Administration
The agency is considering a master file pilot program for premarket approval (PMA) holders whose approved devices are sterilized using radiation, including gamma radiation.
June 13, 2022
Regulatory
2022 PDA/FDA Joint Regulatory Conference
Hosted by the Parenteral Drug Association (PDA), the conference takes place Sep 12 - Sep 14, 2022 in Washington D.C.
June 3, 2022
Regulatory
FDA Flexibilities to Yield Millions of Cans of Additional Infant Formula
U.S. Food and Drug Administration
In the coming months, the FDA will be able to greatly increase the supply of formula, including Abbott EleCare, available to U.S. consumers through international and domestic manufacturing facilities.
May 26, 2022
Inspection
FDA Releases White Paper on Quality Management Maturity
The new white paper discusses developing a framework to evaluate the QMM of pharmaceutical manufacturing sites and the benefits of a rating system.
May 23, 2022
Supply Chain
2022 GS1 Connect: Adapt in San Diego, CA
Expand your professional network and gain new insights on supply chain excellence, June 7-9, 2022. Register by June 1.
May 20, 2022
Market Trends
PDA's Glenn E. Wright, To Be Named President & CEO, March 2023; Richard M. Johnson to Retire
Richard M. Johnson concludes an eventful and successful 13-year term at PDA's helm, handing the reins to Glenn E. Wright, PDA COO.
May 19, 2022
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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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![Some manufacturers continue to use proprietary barcodes for various purposes that existed before UDI along with a UDI barcode. This can confuse downstream users. [Getty]](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2022/07/GettyImages_1277162405.62cf36052a3d5.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
