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1,251 Results
Type: News
Section: Industry News > Regulatory
Regulatory
Counterfeiting's global 'report card'
The Office of the United States Trade Representative (USTR) reports on the proliferation of counterfeit drugs around the world.
May 4, 2010
Regulatory
FDA says no criminal charges from medical device accusations
The U.S. Food & Drug Administration says there won't be criminal charges against FDA officials for abuses in review of medical devices, according to the Wall Street Journal.
April 26, 2010
Labeling/Printing
New FDA regs may prompt cigarette package labeling changes
Agency addresses marketing of tobacco products to minors, announces 'FDA-TRACK' program for transparency and accountability.
April 22, 2010
Supply Chain
GSMS gains an e-Pedigree edge
A software-based system coupled with RFID technology helps Golden State Medical Supply gain a competitive edge in pharmaceutical distribution.
April 16, 2010
Regulatory
How to avoid and respond to FDA 483 letters
With FDA 483 letters expected to increase this year, reflecting the agency's recent staff expansion, this report advises how to avoid and respond to public FDA criticisms--Form 483 Letters--for temperature, humidity and other controlled environments.
April 16, 2010
Medical Device/Packaging
More questions reported about medical device reviews
A U.S. Food and Drug Administration program added to the law for having third parties review new medical devices is reportedly getting another look.
April 13, 2010
Labeling/Printing
Europe shows the way to pharmaceutical serialization
Through government regulations and/or standards organizations, Europe is out in front when it comes to serialization in pharmaceutical and medical device packaging applications.
April 2, 2010
Pharmaceuticals
Theft of drugs at Lilly facility raises multiple concerns
Counterfeiting, diversion, and outright pharmaceutical theft cause plenty of challenges for manufacturers. Can packaging help?
March 22, 2010
Supply Chain
Promoting international standards in Europe
Benefitting global industries, not the interest of individual countries, is part of the focus of ASTM's event in Prague, Czech Republic. New developments include a climatic stress package test.
February 23, 2010
Nutraceuticals/Dietary
FDA warning reminds us of labeling's impact
Seemingly basic details, such as a product's name, or the amount of drug in a tablet, can pose potential patient safety risks if that information is confusing or inaccurate, as two current examples attest.
February 19, 2010
Regulatory
Learning lessons from J&J's product recall
FDA criticizes McNeil Healthcare LLC's response to odor from wood pallets.
February 19, 2010
Pharmaceuticals
Pfizer's European study reveals disturbing counterfeit news
BusinessWeek.com reports that illegal medicine sales in Europe top $14 billion annually, with one in five Europeans saying they've purchased prescription drugs through the Internet, without a doctor's guidance.
February 17, 2010
Regulatory
FDA's rising criticism: A response option
With an expanded staff and power, FDA 483 letters are expected to rise. Here's one option on how to avoid and respond to agency criticism.
February 11, 2010
Regulatory
Pharmaceutical packaging battles global counterfeiting
A mobile authentication service (MAS) launched by Biofem Pharmaceuticals and the Nigerian National Agency for Food and Drug Administration (NAFDAC) is being used in a pilot project in that country in an attempt thwart counterfeit drugs, reports in-Pharma Technologist.com.
February 10, 2010
Regulatory
FDA issues guidance to streamline medical device clinical trials
Bio-Medicine.org eports, "U.S. Food and Drug Administration issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies."
February 5, 2010
Materials
Wanted: Innovative packaging for biotechnology products
Citing Research and Markets' report, "The Future of the Pharmaceutical Packaging Industry--Emerging Economies Poised to Capitalize on Increasing Demand," Pharmacychoice.com reports that the global pharmaceutical packaging market will show a 6.9% compound annual growth rate to reach a value of $68 billion by 2015.
January 29, 2010
Regulatory
FDA flexes its muscle
Several months ago, Packaging World/Healthcare Packaging legal columnist Eric Greenberg pointed out that the U.S. Food & Drug Administration would increase its activity in the new administration under Dr. Margaret Hamburg.
January 25, 2010
Regulatory
Package design helping GSK, FDA to identify bogus alli pills
Differences in markings on primary and secondary packages, as well as the bottle and cap structure, make it simpler for consumers to identify the potentially harmful pills.
January 19, 2010
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