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Archive for the ‘Imports’ Category

US Pharmacopeia Takes Up Supply Chain Security

Monday, December 19th, 2011

The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines. USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...

FDA: Reduce the Opportunity for Crime

Tuesday, July 12th, 2011

During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, "After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." Referring to the heparin-contamination case as a "wake-up call" to supply-chain risks, Allan Coukell, Pew's director of medical programs, said that while ...

What New Laws Will 2011 Bring?

Friday, January 7th, 2011

I was asked for a legislative update on pharmaceutical quality and security efforts a while ago, so I searched thomas.gov and found the below. I thought I would share it because 2011 may bring some changes--although it is still early! Of all the pharmaceutical related bills last year, these seem to ...

Will Standards and Audits Provide Enough Supply-Chain Visibility?

Tuesday, November 16th, 2010

Axendia has released the findings of its study on the global supply chain, and I wasn't at all surprised to see that what life science executives say they need is guidance from industry consortia (59%) and regulatory mandates (51%). "Our research shows that industry executives are relying less on internal ...

Supply Chain Safety in an Era of Globalization

Tuesday, August 17th, 2010

We recently surveyed our readers in our annual salary survey, and many of them referred to the supply chain as a global one, like it or not. (Many, of course, are worried about losing jobs to other countries, but there may be some good news for them on that front.) Fears ...

Are You Terrific at Tracking?

Thursday, March 11th, 2010

If you are wondering what FDA is thinking these days when it comes to drug safety, you should read yesterday's statement from Joshua M. Sharfstein, M.D., FDA's principal deputy commissioner, before the Committee on Energy and Commerce, Subcommittee on Health, U.S. House of Representatives. You may not have all your ...

Whose Imports Are Being Shredded at the Border?

Monday, February 22nd, 2010

FDA is working to tighten U.S. borders when it comes to product safety. In February alone, import alerts for "Detention Without Physical Examination (DWPE)" have been issued for several medical device or drug-like items: unapproved new drugs, active pharmaceutical ingredients that appear to be misbranded, potentially defective medical gloves, devices ...