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Type: News
Section: Industry News > Regulatory
Materials
Pfizer and Allergan Plan to Combine to Form Pfizer plc
Once approved, the merger reportedly would create the world’s largest drugmaker, move Pfizer’s headquarters to Ireland and lowering its U.S. taxes. Job impact of this “inversion” not yet known.
November 24, 2015
Pfizer and Allergan Plan to Combine to Form Pfizer plc.
Pharmaceuticals
Sanofi Study Reveals Perceptions of Counterfeit Medicines
Most Americans associate counterfeiting with consumer goods rather than meds. Sanofi introduces three levels of package protection to battle counterfeits.
November 23, 2015
Most Americans associate counterfeiting with consumer goods rather than meds. Sanofi introduces three levels of package protection to battle counterfeits.
Nutraceuticals/Dietary
FDA takes action to protect consumers from potentially dangerous dietary supplements
Joint government agency sweep culminates with announcement of criminal charges against USPlabs. False labeling, misbranding identified as part of the problem.
November 19, 2015
An FDA sweep resulted in civil injunctions and criminal actions agains 117 various makers and distributors of dietary supplements and tainted products falsely labeled as dietary supplements.
Materials
Just-in-Time Global Logistics Program
QuickSTAT partners with Almac Group to develop a temperature-controlled packaging management system to strengthen their global supply chain.
November 10, 2015
QuickSTAT temperature-controlled facility in Belfast, Ireland.
Regulatory
USP launches GMP audit certification
Dietary ingredient and supplement manufacturers can use this program to demonstrate superior quality systems
November 4, 2015
Regulatory
Sanofi recalls Auvi-Q over potentially inaccurate dosage delivery
There have been 26 reports of suspected device malfunctions in the U.S. and Canada
October 29, 2015
Regulatory
Desperate scientists hope flu patients will agree to real-time clinical trial
Their goal is to help the world be better prepared for the next deadly disease pandemic.
October 26, 2015
Pharmaceuticals
First Serialization Roundtable for CMOs held
Optel Vision and Supply Chain Wizard event encourages open discussion about serialization tools and strategies to prepare for DQSA serialization compliance.
October 20, 2015
Optel and Supply Chain Wizard event encourages open discussion about serialization tools and strategies to prepare for DQSA serialization compliance.
Regulatory
Wrong labeling prompts acetaminophen recall
The 550 mg tablets were incorrectly labeled as 325 mg tablets.
October 15, 2015
Regulatory
Company refuses to stop compounding operations despite FDA quality concerns, recall
During a recent inspection investigators observed insanitary conditions, including poor sterile production practices.
October 14, 2015
Materials
Measuring the true costs of pharmaceutical theft
The total cost of pharma cargo theft could be up to eight times your product’s value. Meanwhile, penalties for criminals remain light.
October 9, 2015
The total cost of pharma cargo theft could be up to eight times your product’s value. Meanwhile, penalties for criminals remain light.
Materials
Watch for ‘smart coolers’ for patients
TR 72— Passive Thermal Protection Systems for Global Distribution: Qualification and Operational Guidance—now available for download.
October 6, 2015
Amsterdam is the site for PDA Europe's Pharmaceutical Cold & Supply CHain Logistics conference.
Pharmaceuticals
New cleaning validation strategy
Presenter notes a shift to continuous monitoring to ensure effective cleaning procedures.
September 30, 2015
LIVE FROM Pharma EXPO: New cleaning validation strategy
Pharmaceuticals
Serialization strategies
Pharma Logic Solutions presenter advises companies to think beyond U.S. requirements, and to take the time to evaluate suppliers.
September 30, 2015
PharmaEXPO-PACK EXPO logo
Package Design
LIVE FROM Pharma EXPO: New product development
Have you considered bringing in a converting partner for your transdermal packaging?
September 29, 2015
LIVE FROM Pharma EXPO: New product development
Materials
LIVE FROM Pharma EXPO: Compliance Lifecycle and TCO
Serialization is a program, not a process, says Innovation Stage speaker.
September 28, 2015
Innovation Stage presentation, '“Compliance Life Cycle Management and TCO.'
Pharmaceuticals
LIVE FROM Pharma EXPO: Pharmaceutical serialization deadlines loom
Successful serialization requires interconnecting packaging machinery and components, as well as internal planning.
September 28, 2015
PharmaEXPO-PACK EXPO
Packaging/Filling
PMMI releases final Innovation Stage schedule
Presenters to address food safety regulatory compliance, child-resistant packaging, automation, workforce engagement, and more at PACK EXPO Las Vegas and Pharma EXPO 2015.
September 22, 2015
The Innovation Stage at PACK EXPO Las Vegas and Pharma EXPO 2015 (Sept. 28–30; Las Vegas Convention Center) will bring together the latest technology and industry leaders in an extensive selection of free educational programming.
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