Regulatory: Page 88

Nutraceuticals/Dietary
Dietary Supplement Sweep
They’re really not unregulated.
December 16, 2015
Eric F. Greenberg is a Contributing Editor and Legal & Regulatory columnist for Packaging World and Healthcare Packaging.
Materials
Medical Devices Enter the Information Age
Despite increasing competitive and regulatory pressures, medical device manufacturers have an opportunity to seize a significantly growing market. Streamlining operations through automation will be key.
December 15, 2015
Progea’s Movicon SCADA system.
Materials
Thailand’s GPO Implements PAS-X MES system
First implementation of its kind in the Thai pharmaceutical industry interfaces to ERP, LIMS, and eQMS for efficiency and compliance.
December 14, 2015
GPO's Thailand site. (Source: The Gov't Pharmaceutical Org.)
Materials
Fisher Dishes on Global Clinical Trials Markets
Technology is advancing so fast that unless you have full-time people keeping track of it, a company's capabilities can become quickly obsolete and they will fall behind their competitors.
December 10, 2015
Refrigerated foam bricks.
Materials
Examining Global IVD Market Factors
Market research indicates optimism for the future for global IVD markets, yet industry consolidation, reimbursement, and excise taxes could slow growth.
December 4, 2015
Examining Global IVD Market Factors
Regulatory
Qualgen Responds to FDA Recommendations
The FDA recently ordered the company to cease all sterile operations.
December 2, 2015
Pharmaceuticals
Industry Collaboration Sheds Light on Serialization
Serialization in pharma packaging is a complicated undertaking for anyone, but CMOs and their customers face additional challenges because responsibilities aren’t always clear-cut. A trend toward industry collaboration, even among competitors, is helping to shed light as companies share their successes and lessons learned.
December 2, 2015
End-to-end serialization.
Nutraceuticals/Dietary
Covectra: Serialization System
A new anti-counterfeit, track-and-race system ensures product integrity.
December 1, 2015
Covectra: Serialization System
Materials
Pfizer and Allergan Plan to Combine to Form Pfizer plc
Once approved, the merger reportedly would create the world’s largest drugmaker, move Pfizer’s headquarters to Ireland and lowering its U.S. taxes. Job impact of this “inversion” not yet known.
November 24, 2015
Pfizer's logo on its New York facility exterior.
Pharmaceuticals
Sanofi Study Reveals Perceptions of Counterfeit Medicines
Most Americans associate counterfeiting with consumer goods rather than meds. Sanofi introduces three levels of package protection to battle counterfeits.
November 23, 2015
Sanofi counterfeit meds chart
Regulatory
FDA’s GE Salmon Announcement Sparks Controversy
Agency announces genetically engineered salmon is safe, drawing a CFS lawsuit. Salmon will be regulated under new animal drug provisions. GE products also have labeling implications.
November 20, 2015
FDA’s GE salmon announcement sparks controversy
Nutraceuticals/Dietary
FDA takes action to protect consumers from potentially dangerous dietary supplements
Joint government agency sweep culminates with announcement of criminal charges against USPlabs. False labeling, misbranding identified as part of the problem.
November 19, 2015
FDA takes action on dietary supplements.
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