Larry Spears’s picture

By: Larry Spears

If you’ve been in the life science industry for awhile, you know it never gets easier but instead more complicated year after year. For example, unique device identification (UDI) requirements, combination product rules, and updated electronic medical device reporting (eMDR) requirements add to the complexity of a quality management system for good manufacturing practices (GMP) requirements.

Kelly Kuchinski’s picture

By: Kelly Kuchinski

Nestlé USA has officially announced its plans to replace the artificial flavors and colors in its chocolate candy products with natural ingredients. This decision will affect more than 250 chocolate bars across 10 brands. The first three modified candy bars—Baby Ruth, Butterfinger, and Crunch—will appear on store shelves by mid-2015.

Michael Causey’s picture

By: Michael Causey

Michael Causey’s picture

By: Michael Causey

The next time you want a cheeseburger, you might consider hopping a plane and flying to Germany. Or France. Or New Zealand. Basically, anywhere but the United States of America.

Michael Causey’s picture

By: Michael Causey

A

s expected, the FDA is shifting more of its regulatory focus toward medical device reporting (MDR). In an Oct. 1, 2014, letter, the agency’s Baltimore district office hit Baltimore-based Electronic Development Labs for not having a MDR procedure. Bad idea. The company may not have recovered very well, either.

Jeff Mazik’s picture

By: Jeff Mazik

If you have been procrastinating on setting up electronic submissions for your adverse event reports to the FDA, you might want to reconsider that decision. Earlier this year, the FDA published its final rule on MedWatch/eMDR reporting.

Gary Minks’s picture

By: Gary Minks

Medical device manufacturers seeking global access for their products can face significant challenges in meeting the regulatory requirements of multiple target markets. The approval process can be even more time-consuming when individual regulatory authorities require an independent audit of a manufacturer’s quality management system, refusing to accept audit reports from the same facility prepared for submission to a regulatory authority in another jurisdiction.

Johns Hopkins University’s picture

By: Johns Hopkins University

A weekend design challenge to develop new protective gear for health workers fighting Ebola drew students, faculty, and clinicians from across Johns Hopkins University and beyond, along with $25,000 in state seed grants to support further development of the best ideas.

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