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Monday, August 31, 2015

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Factory Found in Ukraine Making Over 50 Counterfeit Medicines

Monday, August 31, 2015

Factory Found in Ukraine Making Over 50 Counterfeit Medicines

The Security Service of Ukraine

Kyiv region – Officers of the Security Service of Ukraine dismantled a clandestine lab producing strong and toxic drugs. Half of counterfeit medicines, including known products – metandienone, nandrolone and testosterone, were smuggled, in particular to EU states.

SecuringIndustry.com - 3D-printed fake seals used to mask cargo thefts

Monday, August 31, 2015

SecuringIndustry.com - 3D-printed fake seals used to mask cargo thefts

Cargo thieves have used 3D printers to make fake security seals to hide when a shipment has been compromised.

Rx-360 Summary of Health Canada issued a Notice to Stakeholders - Updates to drug establishment li…

Monday, August 31, 2015

Rx-360 Summary of Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for APIs  http://p0.vresp.com/0RoSI2

Rx-360 Summary of Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for APIs

Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients. On July 31, 2015, Health Canada issued a Notice to Stakeholders - Updates to drug establishment licence ...

Rx-360 Summary of WHO Annex 5 Technical Supplemets  http://p0.vresp.com/24FLOw

Monday, August 31, 2015

Rx-360 Summary of WHO Annex 5 Technical Supplemets  http://p0.vresp.com/24FLOw

Rx-360 Summary of WHO Annex 5 Technical Supplemets

WHO Annex 5 Technical Supplements (to Technical Report Series 992) During The 137th World Health Organisation (WHO) Executive Board (EB) meeting, the Report of the 49th meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations was presented.

Rx-360 Summary of EMA Draft Guideline on Manufacture of the Finished Dosage Form http://p0.vresp.c…

Monday, August 31, 2015

Rx-360 Summary of EMA Draft Guideline on Manufacture of the Finished Dosage Form http://p0.vresp.com/1fmzB0

Rx-360 Summary of EMA Draft Guideline on Manufacture of the Finished Dosage Form

EMA Draft Guideline on Manufacture of the Finished Dosage Form. EMA has issued a draft guideline to clarify the type and level of information that should be included in the CTD Module 3 of the marking authorization application (MAA) dossier with respect to the manufacturing process description.

Germany suspends marketing of 54 drugs tested by GVK Biosciences - The Economic Times

Monday, August 24, 2015

Germany suspends marketing of 54 drugs tested by GVK Biosciences - The Economic Times

Germany's drug regulator has suspended the marketing of 54 medicines clinically tested by India's GVK Biosciences in compliance.

EU lays out draft on new obligatory safety features for medicines

Tuesday, August 18, 2015

Campaign Against Fake Drugs Gains Momentum

Monday, August 17, 2015

Campaign Against Fake Drugs Gains Momentum

FDA and industry support global framework and collaborations to secure the supply chain.

Govt urged to differentiate between spurious, substandard drugs

Sunday, August 16, 2015

One Man's Quest To Combat Counterfeit Drugs With A Suitcase

Wednesday, August 12, 2015

One Man's Quest To Combat Counterfeit Drugs With A Suitcase

Fake and shoddy medications kill about 100,000 people around the world each year. Many "drugs" are no more than just chalk or water. An engineer in Boston is trying to change that.

Insurer claims inside job, seeks $42 million for warehouse heist | JOC.com

Wednesday, August 12, 2015

Insurer claims inside job, seeks $42 million for warehouse heist | JOC.com

A lawsuit claiming that the largest pharmaceutical theft in U.S. history was an inside job at a shipper’s warehouse has been set for trial Oct. 9 in Miami.

Winnipeg Based Drug Company charged with selling unapproved drugs in the U.S.

Wednesday, August 12, 2015

Rough notes and backdated signatures land lidocaine maker FDA warning

Wednesday, July 29, 2015

Rx-360 Summary: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biologic…

Tuesday, July 28, 2015

Rx-360 Summary: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. FDA recently issued the final guidance "Allowable Excess Volume and Labeled Vial Fill SIze in Injectable Drug and Biological Products". This guidance clarifies the FDA regulatory requirements and ...

Rx-360 Summary: Guidance for Industry DSCSA Implementation: Product Tracing Requirements for Dispe…

Tuesday, July 28, 2015

Rx-360 Summary: Guidance for Industry DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy

Guidance for Industry DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy The Drug Supply Chain Security Act (DSCSA) requires dispensers to comply with the new requirements related to product tracing beginning July 1, 2015. On this date, FDA officially issued ...

European Union Bans Hundreds of Drugs Over Clinical Trial Studies

Tuesday, July 28, 2015

European Union Bans Hundreds of Drugs Over Clinical Trial Studies

The European Union has accepted a recommendation to suspend hundreds of drugs that were authorized for use based on what regulators called “flawed” studies conducted by GVK Biosciences, a clinical research organization based in Hyderabad, India.

First part of European fake fighting database linked to securPharm

Thursday, July 23, 2015

Life ban for founder of fake US drug company with $12m in sales

Thursday, July 16, 2015

Import Alert 66-40

Wednesday, July 15, 2015

Import Alert 66-40

Allows retrieval of Import Alerts

Did you pay your GDUFA fees? 29 drugmakers didn't, says US FDA

Monday, July 13, 2015

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