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Friday, July 31, 2015

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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

Fresenius Kabi fined £500,000 after patient death

Monday, July 13, 2015

This is why we need stronger sentencing guidelines! 

Saturday, July 11, 2015

This is why we need stronger sentencing guidelines! 

Counterfeiter evades US lawsuits and gets green card

SHANGHAI (AP) — This could be the story of an American dream. An immigrant family builds a successful business and buys a four-bedroom house in a quiet neighborhood with good schools for their young son. But not all is…

USFDA issues warning letter to Sharon Bio-medicine - The Economic Times

Wednesday, July 8, 2015

USFDA issues warning letter to Sharon Bio-medicine - The Economic Times

The US regulator has issued a warning letter to Sharon Bio-medicine for failing to pay generic drug user fee by its owner for three years.

SecuringIndustry.com - French group launches fake meds awareness campaign

Wednesday, July 8, 2015

SecuringIndustry.com - French group launches fake meds awareness campaign

A public awareness campaign has been launched in France to highlight the dangers of counterfeit medicines.

Israel, Brazil added to list of countries with API GMP standards equivalent to EU

Wednesday, July 8, 2015

World Health Organization Scolds Indian Company for Clinical Trial Violations

Wednesday, July 8, 2015

World Health Organization Scolds Indian Company for Clinical Trial Violations

Yet another contract research organization in India is being scolded for its handling of clinical trial records.

TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma

Wednesday, July 1, 2015

US FDA extends track-and-trace deadline for pharmacies

Wednesday, July 1, 2015

Pharmacy group asks FDA to delay serialization to prevent supply chain disputations. 

Friday, June 26, 2015

Pharmacy group asks FDA to delay serialization to prevent supply chain disputations. 

SecuringIndustry.com - Italian police arrest nine for selling stolen medicines

Wednesday, June 24, 2015

SecuringIndustry.com - Italian police arrest nine for selling stolen medicines

Nine people - including a pharmacist - have been arrested in Italy in relation to the sale of stolen pharmaceuticals.

MHRA Inspectorate

Wednesday, June 24, 2015

MHRA Inspectorate

News and updates from the MHRA Inspectorate

FDA cracks down on over 1,000 illegal online medicine sellers

Tuesday, June 23, 2015

FDA cracks down on over 1,000 illegal online medicine sellers

The U.S. Food and Drug Administration said on Thursday it had sent warning letters and seized potentially dangerous, unapproved medicines and medical devices from more than 1,050 websites

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