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Archive for January, 2009

Delta Defines Stance On Loggers

Friday, January 30th, 2009

Delta Cargo is accepting data loggers containing lithium batteries, but they have to be approved as meeting DOT hazardous materials regulations (HMR), and FAA electromagnetic compatibility testing. The carrier had advised customers in November that it wouldn’t carry devices containing the batteries, after DOT’s Pipeline & Hazardous Materials Safety Administration issued ...

The Envelope, Please

Thursday, January 22nd, 2009

Awards season has arrived, and packaging designers and manufacturers are among those invited to bask in the spotlight. DuPont is gearing up for its 21st Awards for Packaging Innovations, and this year's competition aims to honor innovative packages that can help create a more sustainable world. DuPont Packaging collected some of ...

A View on Global Outsourcing

Friday, January 16th, 2009

The increase in global outsourcing has raised more than a few red flags on the legislative front. Pending bills on the issue will undoubtably attract close scrutiny in Congress this year. Concern has been voiced over the safety of off-shore manufacturing, as well as on its impact on domestic employment. Country-of-origin labeling ...

Standardized Numerical Identifiers for Drugs: File Comments by Tax Day

Thursday, January 15th, 2009

FDA is suggesting the voluntary use of a standardized numerical identifier (SNI) on prescription drug packages. You now have 90 days (from the Federal Register publication date) to comment on "Guidance for Industry: Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages." The draft guidance ...

Brown’s Bill Revisited

Thursday, January 15th, 2009

The inauguration countdown continues, and so does the anticipation of what a new administration will mean to bills introduced to Congress. One bill in particular would affect packagers. The Transparency in Drug Labeling act (S. 3633) would require country-of-origin labeling of active pharmaceutical ingredients (APIs) and excipients of finished ...

Calling All Medical Device Manufacturers: Register Now to Hear FDA on UDI

Wednesday, January 14th, 2009

Only 300 attendees will be able to register to attend in person FDA's just-announced "Unique Device Identification Public Workshop," to be held on February 12, so grab your seats now. The agency will discuss the unique device identifier, placement and technology, the unique device identifier database, and implementation and adoption. Standards, ...

Over-the-Counter Countdown

Wednesday, January 7th, 2009

FDA has announced a delay on OTC labeling regulations. In the Federal Register of January 2, 2008 (73 FR 196), FDA asked for feedback on its guidance for new labeling requirements for OTC drugs marketed without an approved application. Last week, the latest update of the guidance draft set that ...

Generics Help Slow Drug Cost Increases, But Technology, Too, Is Needed for Further Savings

Tuesday, January 6th, 2009

The numbers on 2007 drug spending are coming in, and I am trying to piece a number of reports together to see if they all add up. (It feels like I am about a year late in writing this story, but really, the 2007 numbers were just released today!) The Centers ...

Additions to Your Post-Holiday Shopping List

Friday, January 2nd, 2009

How many of you routinely log on to the Internet to "shop" consumer auction sites for your own products? Did you know that you can buy over-the-counter allergy medicine and smoking-cessation drugs? Earlier this week I even found catheter insertion kits and enteral-feeding pump bags and tubes. "BAGS NEW in ...