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1,251 Results
Type: News
Section: Industry News > Regulatory
Medical Device/Packaging
FDA's UDI proposal presents industry 'a window of opportunity'
FDA's proposed regulation to set up Unique Device Identifiers scheduled for a seven-year phase-in to minimize burdens on regulated businesses.
July 18, 2012
Regulatory
Serialization urgency: Industry has failed to sound the alarm
Resources are being stretched so thin, hoping for another California delay is not going to cut it.
July 12, 2012
Regulatory
Serialization need not be complex
You don't have to wait for California's 2015 target date to reap benefits--a modular, flexible approach to data is the key to keeping it simple.
July 11, 2012
Regulatory
Will the Affordable Care Act have an impact on your business?
Healthcare thought leaders and organizations address the act's impact on costs, regulations, and innovation in the life sciences community.
July 6, 2012
Labeling/Printing
Need to avoid product and label mix-ups? Try new ISPE Guide.
New guidance now available for designing and constructing packaging, labeling, and warehousing facilities.
July 3, 2012
Packaging/Filling
Quotient Clinical, Capsugel collaboration announced
Liquid capsule filling and sealing technology a part of the effort to fast track development and clinical assessment of lipid-based formulations.
June 27, 2012
Traceability/Serialization
Combatting diversion offers another driver for serialization
By providing a unique serial number on all levels of packaging and sending those details to a database, traceability can extend to patients-and diverters.
June 22, 2012
Robotics/Automation
LIVE FROM ACHEMA 2012: Achema delivers a futuristic perspective
Trend reports look ahead to anti-counterfeiting, biotherapeutics, container-sized production, and automation.
June 21, 2012
Packaging/Filling
LIVE FROM ACHEMA 2012: Transmodules for Hoffmann LaRoche clinical studies
Gerhard Schubert's Achema booth demonstrates for first time its TLM packaging line flexible enough to produce batch sizes of one.
June 19, 2012
Sustainability
Regulatory perspectives with a global twist
Pharmaceutical and medical device leaders think globally when it comes to regulatory matters.
June 18, 2012
Regulatory
Filling errors, counterfeit packs gain FDA's attention
Hospira's prefilled cartridges are overfilled, but not recalled. Counterfeit versions of Teva's Adderall use wrong package, with print misspellings.
June 7, 2012
Sustainability
Wanted: Suppliers offering packaging material innovation and expertise
Hard-pressed to do more with less, manufacturers rely on suppliers with industry knowledge, with an eye on sustainability and validated processes.
June 4, 2012
Regulatory
No 'one-size-fits-all' approach to pharmaceutical anti-counterfeiting
Securing the distribution system will help, but eliminating counterfeit pharmaceuticals may be impossible.
May 24, 2012
Regulatory
Designing with one hand tied behind your back
The healthcare field presents some of the stringent product packaging rules, yet restrictions can be used to your brand's advantage.
May 18, 2012
Regulatory
FDA broadens horizons in more than one way
Many medical products, and more than 80% of pharmaceutical active ingredients are imported, so FDA's oversight internationally becomes more demanding.
May 11, 2012
Labeling/Printing
Becton, Dickinson takes proactive stance on device identification
Medical technology company/Mercy Health System's joint packaging data integration program includes some 650 products and 950 global trade ID numbers.
May 4, 2012
Regulatory
JETT seeking input on User Requirement Specifications
Two current projects include revising URSs to a new tablular format and developing URS's for serialization.
May 3, 2012
Labeling/Printing
Toolkit helps South Carolina hospitals reduce mislabeled blood specimens
'Final Check' process aims to design healthcare systems and help healthcare providers make choices in those systems to produce better patient outcomes.
May 2, 2012
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