Regulatory

Equipment such as this horizontal form/fill/seal machine, which is designed to meet USDA meat, poultry, dairy, and 3-A Sanitary Standards, has a head start in FSMA compliance because the underlying best practices are the same under the new FDA law. (Photo: Pro Mach/Ossid)
Feature Article
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How Companies Can Tap Their Machinery Suppliers for FSMA Compliance

Best practices for food companies affected by the FSMA for calling upon their equipment suppliers for support.
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Implementing a food safety plan under FSMA requires continual documentation of ongoing activities, which enhances a company’s preparedness to minimize the impact of a food safety incident.
Feature Article
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Recordkeeping Key to the New Era of Prevention

A primary goal of the FSMA is greater prevention. While this has always been a general goal of food safety practices industry-wide, the new requirements are designed to mandate for all companies what many of the leading companies consider best practices today.
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.
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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.

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