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Industry News: Page 296
Medical Device/Packaging
Checking up on healthcare packaging
Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain. (Part I of II)... Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA. The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.
January 2, 2007
Regulatory
U.S. Senate approves von Eschenbach to head FDA
Some guys in government service wait until they are actually in office to be the subject of controversy. Andrew von Eschenbach got a head start.
December 15, 2006
Regulatory
Equipment qualification protocols and validation
I've heard it said that the number of packaging machinery and material suppliers is limited in the pharmaceutical industry.
December 10, 2006
Regulatory
Taking the pulse of RFID for pharmaceuticals
Pharmaceutical firms face a different set of realities about whether or not to use RFID than do consumer packaged goods companies.
December 10, 2006
Regulatory
Anti-counterfeiting process
DataLase's DataLase is a technique capable of producing tamper-resistant images.
November 17, 2006
Adherence/Delivery
Will marketing drive 'smart' pharmaceutical packaging?
I recently paid a visit to a representative of a supplier of healthcare packaging materials who showed me sophisticated "Smart" packages--this particular application was for clinical trials.
November 17, 2006
Regulatory
Institute calls for label symbol, funding, and reorganization to fix drug safety
More and more people are beginning to think that the FDA system for assuring the safety of drugs--especially new drugs--is broken.
October 24, 2006
Adherence/Delivery
RFID breaks new ground in clinical trial packaging
A macrolide azithromycin chronic obstructive pulmonary disease (COPD) Phase III study is using Med-ic RFID smart sensors embedded in blister packs. Sponsored by the National Institute of Health, the multiyear, double-blind study will enroll more than 1,100 patients at 10 clinical centers across the country.
July 10, 2006
Labeling/Printing
New Rules For Patient Package Inserts
In June, new Food and Drug Administration rules for the format and content of patient package inserts in prescription drugs became effective. The new format emphasizes "highlights" of the label information, provides a table of contents, requires the information to appear in a different order, and sets forth specified graphic requirements. That goes along with a requirement put in place late last year calling for drug makers to submit labeling information in electronic format, for easier searching and cross-referencing. Says the FDA, "These revisions will make it easier for healthcare professionals to access, read, and use prescribing information, and will enhance the safe and effective use of prescription drug products."
July 10, 2006
Medical Device/Packaging
FDA Analyst Delivers Medical Device Labeling Insights
At a June 6 Medical Design & Manufacturing East conference session, Food and Drug Administration regulatory policy analyst Arthur Yellin offered the following advice on medical device labeling:
July 10, 2006
Regulatory
RFID: Item-level tagging accelerates for pharmaceutical packaging
Crucial decisions need to be made by drug companies now, insists the CEO of a silicon chip maker.
July 10, 2006
Regulatory
Using packaging to build consumer trust for Internet drug purchases
In conducting research for his presentation at the recent HealthPack 2006 conference in Dallas, Joe Kornick "found a real and growing need for medical and pharmaceutical companies to give special consideration to their Internet packaging."
June 10, 2006
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