Regulatory

Column/Opinion
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Food fraud (and related issues) to the forefront

We’re still early in 2014, but “food fraud” might be this year’s hot phrase.
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Feature Article
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The certainties of life: Death, taxes...and regulations

Challenges related to new EU labeling regulations for the management and transparency of cosmetic product information can be addressed through a data-centered approach.
3D printing offers exciting possibilities for medical device developments.
Column/Opinion
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Medical device developments that pack the 'wow' factor

With two considerable medical device packaging events just around the corner, intriguing medical device announcements center on everything from engineered human organs to 3D printing to talking apps.
Column/Opinion
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FDA wants trans fats out of food, but what else?

When FDA announced its tentative determination last November that partially hydrogenated oils were not generally recognized as safe, they may have announced a new, more aggressive era in the regulation of food ingredient and food contact materials.
RAPS launches 2014 global regulatory survey.
News
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RAPS launches 2014 global regulatory survey

Survey asks regulatory pros about their jobs, backgrounds, and compensation. Results will be available in June.
Dr. Michael Drues, Vascular Sciences
Column/Opinion
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Printing medical devices at home is just the beginning: Part II

Is it time for a new business model for medical devices? And where does packaging fit into advanced 3D printing technology?
This is a purchased photo of a drug strip made by Ranbaxy and used solely for illustrative purposes.
News
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FDA prohibits Ranbaxy's Toansa, India facility from producing and distributing drugs for the U.S. market

The facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in Jan. 2012.
Regulatory issues represented the primary challenge for combination product makers, closely followed by processing and manufacturing, and then fill/finish and packaging. These details provide keen insight into manufacturer needs, particularly for consultants and suppliers involved in these topical areas.
News
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Regulatory burdens weigh on combination product manufacturers

Regulatory matters, processing and manufacturing, as well as fill/finish and packaging rank as the most challenging areas for makers of combination products.
Senator Charles Schumer calls for safer packaging for children’s medicine bottles in effort to help prevent emergency room visits.
News
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Could 'flow restrictors' help reduce medication overdoses?

Senator Charles Schumer calls for safer packaging for children’s medicine bottles in effort to help prevent emergency room visits.
Gail E. Radcliffe, Ph.D., is President of Radcliffe Consulting, Inc.
Column/Opinion
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Regulatory issues factor heavily into the IVD market

In this question-and-answer dialogue, Gail Radcliffe of Radcliffe Consulting discusses in vitro diagnostics, focusing on regulatory and labeling issues.

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