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Regulatory: Page 101

Materials
LIVE FROM PHARMAPACK: Global pharma community accepts GS1 standards for identifying and capturing serialized codes
Non-profit group now turns attention to standards for sharing the data.
February 12, 2015
Counterfeiting info graphic sourced from Pharmapack website.
Packaging/Filling
Nelipak Healthcare Packaging: Enhanced tray heat sealer
To be displayed at this year’s MD&M show in Anaheim, the NX-T1 tabletop unit incorporates customer input acquired during a two-year period.
February 11, 2015
Nelipak Healthcare Packaging: Enhanced tray heat sealer
Regulatory
Hamburg’s resignation draws media reaction
FDA commissioner to step down in March, with Ostroff to serve as acting commissioner while Califf is named Deputy Commissioner for Medical Products and Tobacco.
February 10, 2015
Pharmaceuticals
Pfizer to acquire Hospira
The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions and approval of Hospira's shareholders, and is expected to close in the second half of 2015.
February 9, 2015
Materials
Sanofi launches Afrezza inhalable insulin for diabetes treatment
Single-dose cartridges and a small, discreet, and easy-to-use inhaler give patients an option to injections to help with glycemic control in adults with diabetes.
February 4, 2015
Sanofi launches Afrezza inhalable insulin for diabetes treatment.
Medical Device/Packaging
FDA requests $4.9 billion budget for FY 2016
The 9% increase over the FY 2015 budget aims to implement the agency’s Food Safety Modernization Act and improve quality and safety of medical products.
February 2, 2015
The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of
Pharmaceuticals
Cold Chain Technologies: Temperature-controlled containers
A push-button, temperature-controlled shipping container maintains temperatures for 96 hours.
February 2, 2015
Cold Chain Technologies: Temperature-controlled containers
Regulatory
Large Ebola vaccine trial opens in Liberia
The study is designed to enroll approximately 27,000 healthy men and women aged 18 years and older.
February 2, 2015
Materials
Recipharm delivers serialization project in China
Contract development and manufacturing organization works with unnamed pharmaceutical company, resulting in 57 successful batches since Feb. 2014.
January 30, 2015
Recipharm, a contract development and manufacturing organization, announced its readiness for serialization.
Materials
3M Drug Delivery Systems: Microneedles
hMTS is a hollow microneedle device available for clinical trials.
January 30, 2015
3M Drug Delivery Systems: Microneedles
Regulatory
First generic version of Nexium approved
Ivax Pharmaceuticals, Inc. has gained approval to market esomeprazole in 20 and 40 milligram capsules.
January 29, 2015
Regulatory
Report looks at timeliness of FDA approvals
Although FDA drug and device approval time is improving, consistency needs to be key.
January 29, 2015
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Temp Control/Cold Chain
How a Blood Bank Cyberattack Put Remote Access on Blast
An attack on refrigeration controls highlights the role of thermal packaging, independent temperature monitoring, and emergency transfer plans in protecting life sciences products.
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When Worst Case Becomes Real: ISO 11607 and the Risk of Packaging Failure
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AI-enabled X-ray Inspection Software Platform
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