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Archive for March, 2010

A Case of Déjà Vu

Thursday, March 25th, 2010

I thought this story sounded familiar! Last week the U.S. Attorney's Office in the Southern District of Florida reported that defendants "Jose Castillo of Ft. Lauderdale, Federico M. Fermin of Miami Beach, and Terri L. DeCubas of Pembroke Pines were indicted on charges of mail fraud, distribution of prescription drugs without ...

Are You Ready for 32 Million New Customers?

Monday, March 22nd, 2010

Your reaction to this headline might reveal your feelings toward the passage of healthcare reform. You might see reform as increasing the number of potential patients that could be prescribed your company's drug or treated with your company's medical device---or you could be dreading the costs to your company to ...

More on FDA and Calendarized Unit-Dose Packaging

Monday, March 22nd, 2010

I have been asked to clarify an earlier post, FDA: "We are not opposed to patient unit-dose packaging." In that post, I shared a statement from FDA. I was then encouraged to contact W. Peter Rickman, Director, Division of Labeling and Program Support, Office of Generic Drugs, who provided an updated ...

Depressing Weekend: Eli Lilly Victim of Theft

Wednesday, March 17th, 2010

Prozac and Cymbalta are among the products stolen from Eli Lilly and Co. over the weekend, the company reported today.  More than 30 lots of products were stolen from the company's distribution operations in Enfield, CT. "Since early Sunday morning, Lilly has taken quick and appropriate actions to ensure the safety ...

Pinholes Found in IV Product Packaging

Monday, March 15th, 2010

Pinholes may be at the root of a recall issued in February of nearly a thousand medical device products. According to FDA, Teleflex Inc. offered an update on the Arrow International Inc. recall of all lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow ...

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 ...

Don’t Pass on Poststerilization Testing

Wednesday, March 10th, 2010

FDA's Quality System Regulation states that as part of "final acceptance activities. . . each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria." Why the regulation lesson? I just read today that Guidewire Technologies ...

FDA: “We are not opposed to patient unit-dose packaging”

Tuesday, March 9th, 2010

A while ago we shared a letter from the Healthcare Compliance Packaging Council to FDA regarding an FDA decision out of the Office of Drug Safety “that prohibits generic drug manufacturers from 'calendarizing' unit dose blister cards, strips, and other packaging formats.” We hadn't heard anything official from FDA, so I ...