Archive for February, 2010
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 ...
Posted in Imports | No Comments »
Monday, February 22nd, 2010
Polyethylene is commonly used for drug packaging. So who could ever have expected that it could result in a product's clinical failure?
Biotec Pharmacon reported today in a press release that its candidate, SBG, used in a diabetic ulcer program, "may have been inactivated as a result of interaction with polyethylene ...
Posted in clinical trials, Quality | 2 Comments »
Wednesday, February 17th, 2010
I hope you read this news in today's PMP News.com Daily Newsletter: "Hospital makes a profit trading NHS drugs in Europe." Before you click to read it, though, I just want to share a few quick thoughts.
This story shocked me. We've reported instances of tampering and theft by healthcare professionals ...
Posted in Diversion, serialization, Tampering, Theft | 3 Comments »
Tuesday, February 16th, 2010
I have always heard that historically, FDA has pretty much just regulated the manufacture and marketing of the products it oversees (i.e., pharmaceuticals and medical devices, among others) but not the practice of medicine itself. Currently, though, FDA can mandate certain activities under a risk evaluation and mitigation strategy (REMS). ...
Posted in FDA, Hospital, Labeling, Medication Guides, REMS, Safety | No Comments »
Friday, February 12th, 2010
Medical device packagers who have attended the last few HealthPack events still remember the valuable packaging feedback provided by nurses. From an advance survey to a live interactive panel, nurses have provided specifics on packaging preferences, challenges, and wish lists.
HealthPack 2010 will again feature nurse input during the morning session ...
Posted in Medical Devices | 2 Comments »
Tuesday, February 9th, 2010
Years ago, one of our editorial advisory board members (actually, more than one) told me that medical device manufacturers were seeking a cookbook-approach to medical packaging. Mix this, test that, age this, store that, and so on.
With the wonderfully detailed ISO 11607 and consensus-driven ASTM standards, we are getting pretty ...
Posted in Testing | No Comments »
Wednesday, February 3rd, 2010
Growth in bio-engineered products more susceptible to variations in temperature and humidity. Emerging global markets that require packaging that will stand up to the handoffs, complexities, and climate variations of extended supply chains. The proliferation of guidelines and regulations from countries around the world promoting best practices for handling sensitive ...
Posted in Cold Chain | No Comments »
