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Monday, February 08, 2016

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Increased scrutiny requires digging deeper into the supply chain

Friday, February 5, 2016

Increased scrutiny requires digging deeper into the supply chain

As threats to the pharmaceutical supply chain prevail, the industry is seeing increased regulatory scrutiny as well as more inspection requirements, says industry panel.

February 1, 2016: Pakistani Man Makes Appearance in U.S. District Court in Denver Following Indict…

Thursday, February 4, 2016

February 1, 2016: Pakistani Man Makes Appearance in U.S. District Court in Denver Following Indictment and Arrest for Sale and Distribution of New, Misbranded and Counterfeit Prescription Drugs

February 1, 2016: Pakistani Man Makes Appearance in U.S. District Court in Denver Following Indictment and Arrest for Sale and Distribution of New, Misbranded and Counterfeit Prescription Drugs

Ipca: US FDA Warning Letter for Indian API plants 'unsurprising'

Monday, February 1, 2016

Boston Scientific Sued For Racketeering: Don't Let This Happen to You! http://p0.vresp.com/YoFrpp

Wednesday, January 20, 2016

Boston Scientific Sued For Racketeering: Don't Let This Happen to You! http://p0.vresp.com/YoFrpp

Boston Scientific Sued For Racketeering: Don't Let This Happen to You!

Boston Scientific Sued For Racketeering: Don't Let This Happen To You! supplier selection. Selecting a supplier and providing on-going oversight is important and difficult to achieve, especially when using suppliers in parts of the world with significant known counterfeit and data integrity ...

Read the Rx-360 Summary of the WHO GMPs Biological Products http://p0.vresp.com/Yb6HbC

Tuesday, January 19, 2016

Read the Rx-360 Summary of the WHO GMPs Biological Products http://p0.vresp.com/Yb6HbC

Read the Rx-360 Summary of the WHO GMPs Biological Products

WHO GMPs for Biological Products. WHO issued a final guidance on GMP for Biological Products. This document is intended to serve as a basis for establishing national guidelines for GMP for biological products. These guidelines apply to the manufacture, control, and testing of biological products ...

US FDA Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fis…

Tuesday, January 19, 2016

US FDA Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development http://p0.vresp.com/ULdnVg

US FDA Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development

Medical Device User Fee and Modernization Act; Notice to Public of Web Site Location of Fiscal Year 2016 Proposed Guidance Development. On December 29, 2015, FDA announced the web site location where the Agency will post two lists of guidance documents that the Center for Devices and ...

Read the Rx-360 Summary of the WHO GMPs Biological Products

Tuesday, January 19, 2016

Read the Rx-360 Summary of the WHO GMPs Biological Products

WHO GMPs for Biological Products. WHO issued a final guidance on GMP for Biological Products. This document is intended to serve as a basis for establishing national guidelines for GMP for biological products. These guidelines apply to the manufacture, control, and testing of biological products ...

US FDA and French regs hit separate Chinese API makers with warnings

Monday, January 18, 2016

U.S. emergency departments face serious drug shortages

Thursday, January 7, 2016

U.S. emergency departments face serious drug shortages

Join Rx-360 at a Free Security Technology Vendor Presentation Event  http://p0.vresp.com/kkvtIN

Wednesday, January 6, 2016

Join Rx-360 at a Free Security Technology Vendor Presentation Event  http://p0.vresp.com/kkvtIN

Free Security Technology Vendor Presentation Event

Security Technology Vendor Presentation Event Location: Pfizer's Collegeville, Pennsylvania Facility Date: February 3, 2016. Time: 8:00 am to 5:00 pm. Contact: Brad Elrod @ [email protected] On behalf of Rx-360 Cargo Theft/High Risk Areas Workgroup, in partnership with the Pharmaceutical ...

Rx-360 Releases How to Manage Critical Vendors http://p0.vresp.com/RvF2CR

Tuesday, December 29, 2015

Rx-360 Releases How to Manage Critical Vendors http://p0.vresp.com/RvF2CR

Rx-360 Releases How to Manage Critical Vendors

Rx-360 Releases How to Manage Critical Vendors. The Rx-360 Supplier-Led Working Group is proud to announce the release of its most recent white paper: Managing Critical Vendors. The paper covers the key aspects of vendors that supply manufacturers (customers) of regulated products, ...

Rx-360 Releases for FREE the Best Practices for Quality Agreements Guide http://p0.vresp.com/b7bfZe

Tuesday, December 29, 2015

Rx-360 Releases for FREE the Best Practices for Quality Agreements Guide http://p0.vresp.com/b7bfZe

Rx-360 Releases for FREE the Best Practices for Quality Agreements Guide

Rx-360 Releases for FREE the Best Practices for Quality Agreements Guide. qaulity agreement. The Rx-360 Supplier-Led Working Group is proud to announce the release of the Rx-360 Best Practices for Quality Agreements Guide. The Best Practices Quality Agreement Guide is intended to assist both ...

CDER Alert: FDA Warns of Potential Contamination of Drug Shipments from Explosions in Tianjin City

Thursday, December 24, 2015

CDER Alert: FDA Warns of Potential Contamination of Drug Shipments from Explosions in Tianjin City

[12/22/2015] FDA is alerting drug compounders and manufacturers that drug shipments from Tianjin, China may be at risk of chemical contamination. FDA increased surveillance of drug shipments following two massive explosions at Tianjin Dongjiang Port Ruihai International Logistics Co., ...

A drugmaker that produces 30 percent of the influenza vaccines used in Japan followed unapproved m…

Wednesday, December 16, 2015

A drugmaker that produces 30 percent of the influenza vaccines used in Japan followed unapproved manufacturing procedures for vaccines and blood products for 40 years and systematically faked records to hide its wrongdoing, according to a scathing report compiled by a third-party committee.

Drugmaker blasted for 40-yr cover-up

A drugmaker that produces 30 percent of the influenza vaccines used in Japan followed unapproved manufacturing procedures for vaccines and blood products for 40 years and systematically faked records to hide its wrongdoing, according to a scathing report compiled by a third-party committee.

A world map where most commodities are exported

Wednesday, December 16, 2015

A world map where most commodities are exported

http://p0.vresp.com/erW97V

Wednesday, December 16, 2015

http://p0.vresp.com/erW97V

Only 12% of Patients Feel They Have Enough Information About Counterfeit Medicines

Rx-360 Applauds Sanofi For Sharing Their Study Results On Counterfeit Medicines to Better Serve Patients. logo-sanofi. Impact of Counterfeiting Trafficking in fake medicines was estimated to be worth $200 billion in 2014 versus $75 billion in 2010. 1. Sixty-two percent of tablets purchased on ...

Who's investigating fake Chinese goods? Fake investigators - Friday, Dec. 11, 2015 - InkaBinka: Vi…

Friday, December 11, 2015

Who's investigating fake Chinese goods? Fake investigators - Friday, Dec. 11, 2015 - InkaBinka: Visual News Summaries in 20 Seconds!

China's murky anti-counterfeiting industry is plagued with severe fraud, according to a new AP investigation.

Top Indian business group warns pharma industry to step up its quality game

Thursday, December 10, 2015

Top Indian business group warns pharma industry to step up its quality game

A top business organization has warned the Indian pharmaceutical industry about what the FDA has been tacitly indicating for years with product bans and warning letters. If India doesn't get its "house in order," the country is going to suffer the consequences of seeing its pharma industry fall behind.

Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Sta…

Thursday, December 10, 2015

Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination

The affected lots may potentially pose serious safety risks for U.S. patients who use or receive injectable drug products compounded with the affected baclofen, especially when administered directly into the spinal column.

From Securing Industry: A survey of medicines sold in the Philippines has revealed alarmingly high…

Thursday, December 3, 2015

From Securing Industry: A survey of medicines sold in the Philippines has revealed alarmingly high levels of illegal products, according to the country's Department of Health. All told, the survey found that 81 per cent of the 546 products analyzed has not been registered by the Philippines Food and Drug Administration (FDA), of which 13 per cent were diverted products intended for sale in other markets and 6 per cent were counterfeit.

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