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Regulatory: Page 92

Materials
Contract packager unveils technology for meeting serialization requirements
PCI’s ‘FlexLine’ standalone service compliments a company’s integrated serialization technologies.
September 16, 2015
PCI line with serialization.
Labeling/Printing
Linx Printing Technologies: Ink-jet printer
Linx 8900 is a next-generation, easy-to-use CIJ printer that maximizes efficiencies.
September 14, 2015
Linx Printing Technologies: Ink-jet printer
Regulatory
FDA issues draft guidance on labeling for new animal drugs
Describes what the agency considers when deciding to take regulatory action; public comments accepted until 60 days after it publishes in the Federal Register.
September 9, 2015
Animal vaccine label, for illustrative purposes only.
Pharmaceuticals
CDC funding aims to combat Rx drug overdoses
Commits $20 million in 2015 to launch program to address ‘national epidemic,” of deaths from prescription opioids and heroin.
September 4, 2015
CDC funding to combat overdoses
Materials
Report examines biosimilars market drivers
Manufacturers see opportunity as blockbuster biologics face patent expiries, with emerging markets representing an easier ‘launching pad’ for biosimilars/follow-on biologics.
September 3, 2015
Biosimilars image supplied by Allied Market Research
Pharmaceuticals
Regulations, technology, integrated supply chain battling counterfeiters
Yet it could take global governance, stiff penalties/fines—and more—to truly deter medication counterfeiting.
September 1, 2015
Counterfeit package example (Source: FDA)
Regulatory
Dietary supplements recalled over toxic ingredient
Sample analysis by the FDA showed these products contain an undeclared drug.
August 26, 2015
Materials
Open-SCS webinar set for Sept. 3
Healthcare providers drive Open-SCS Initiative as a serialization compliance solution.
August 26, 2015
Materials
Three primary cold chain packaging pain points and priorities
Along with preventing temperature excursions, three priority issues are regulatory compliance, reducing costs, and emerging markets.
August 25, 2015
Credo production line.
Adherence/Delivery
Schreiner MediPharm: Booklet label for folding cartons
Developed in a joint project with Edelmann, label combines a folding box with a booklet label applied to the outside.
August 14, 2015
Schreiner MediPharm: Booklet label for folding cartons
Materials
HealthPack accepting presentation abstracts for 2016 event through Aug. 24
Sterilization methods, UDI developments, test method validation among the topics sought by event team.
August 14, 2015
HealthPack 2016 at the New Orleans' Astor Crowne Plaza.
Packaging/Filling
Capsule filler enhances Sharp Clinical Services' production
Machine’s in-process weight control system and tablet feeder provide ‘radical change’ to the company’s capsule production.
August 13, 2015
MG capsule filler benefits Sharp Clinical Services.
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Commercial blood bank refrigerator with multiple shelves storing blood bags in a medical laboratory setting
Temp Control/Cold Chain
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An attack on refrigeration controls highlights the role of thermal packaging, independent temperature monitoring, and emergency transfer plans in protecting life sciences products.
Sealed sterile syringe with needle in clear plastic packaging on dark background
Medical Device/Packaging
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Researcher in lab coat examining mannequin head with blue eye patches during cosmetic or skincare product testing
Pharmaceuticals
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Packaging/Filling
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