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1,251 Results
Type: News
Section: Industry News > Regulatory
Supply Chain
Pharmaceutical Packaging Forum coming to Philadelphia
Spend an educational day with your peers and solution providers at the Pharmaceutical Packaging Forum (PPF) in Philadelphia March 29. The event is produced by Summit Publishing Company, publishers of Healthcare Packaging and Packaging World business publications. Seats are going quickly, so register soon.
February 8, 2007
Medical Device/Packaging
Anaheim gears up for MD&M show
Abbott Vascular's Jan Gates will chair a Feb. 15 Medical Device and Packaging session that includes Part I, Packaging Engineering, from 9 a.m. until 12 p.m., followed by Part II, Packaging Validation and Compliance from 1 p.m. to 4 p.m. The session is part of Medical Design and Manufacturing West event at the Anaheim Convention Center in Anaheim, CA. The conference will be held Feb. 12-15, while the exposition runs from 10 a.m. until 5 p.m. Feb. 13-14, and 10 a.m. to 4 p.m. Feb. 15.
February 5, 2007
Regulatory
Clinical trials outsourced to China
Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005.
February 5, 2007
Adherence/Delivery
Clinical trials outsourced to China
Half the 1,200 clinical trials conducted by a dozen of the largest U.S. pharmaceutical companies were conducted offshore in 2005. So says a report from management consultancy A.T. Kearney, "Make Your Move: Taking Clinical Trials to the Best Location." The report cites China as the best bet for outsourcing clinical trials.
January 29, 2007
Regulatory
JETT equipment acquisition model set to fly
Need to get on the same page with your supplier(s) and consultant(s) in commissioning and qualifying packaging machinery? Try boarding JETT.
January 27, 2007
Regulatory
JETT equipment acquisition model set to fly
Need to get on the same page with your supplier(s) and consultant(s) in commissioning and qualifying packaging machinery? Try boarding the Joint Equipment Transition Team , or JETT. A small team of end users, suppliers, and consultants finalized the language and a complex diagram for a JETT equipment acquisition model that's been in the works for more than a year during a January 18 meeting hosted by Abbott Laboratories at its Waukegan, IL, facility.
January 22, 2007
Package Design
Checking up on healthcare packaging
Drug delivery devices, advances in combination products, and biologics/biopharmaceuticals will present both challenges and opportunities for packagers. New packages and drug delivery methods for over-the-counter (OTC) drugs, nutraceutical and cosmeceutical products are appearing on retail drug and grocery store shelves. (Part II of II)
January 15, 2007
Medical Device/Packaging
Abbott's bioabsorbable stent packs promise
Bioabsorbable stents, such as Abbott's Absorb, may soon open a new pathway in the treatment of coronary artery disease, and challenge the packaging process. In late October, Abbott Park, IL-based Abbott Laboratories delivered encouraging news regarding the initial results of a clinical trial involving its Absorb bioabsorbable drug-eluting stent for the treatment of coronary artery disease.
January 12, 2007
Pharmaceuticals
U.S. government warns pharmaceutical industry--new drug development is 'stagnant'
According to a report posted on DrugResearcher.com , the Government Accounting Office has warned the pharmaceutical industry that although their investment in research and development has increased 147% between 1993 and 2004, New Drug Applications have only risen 38%.
January 11, 2007
Pharmaceuticals
Adverse event reporting tightens for OTCs and dietary supplements
The packagers of over-the-counter drugs (OTC) and dietary supplements will soon need to label their products with contact information to allow consumers to report possible injuries or illnesses. The packagers, in turn, will have to report serious adverse events to the Food and Drug Administration, and keep records of the events. The law goes into effect December 22, 2007.
January 8, 2007
Adherence/Delivery
Smart packaging in drug development: The disconnect in clinical trials
Electronic compliance monitoring packaging has been around for years, yet many pharmaceutical companies are unable to quantify the return on investment of smart packaging. Pundits who predict the future of packaging often talk bout the rise of smart packaging. What exactly is a smart package? One U.K. Web site cites examples such as time-temperature food quality labels, self-heating or self-cooling containers—any package enhanced to deliver additional consumer convenience.
January 5, 2007
Robotics/Automation
Validation software
* Transfer Operational Qualification (TOQ) is for life-sciences firms looking to reduce the cost and challenge of software validation
January 5, 2007
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
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