Daily Archives: May 4, 2016

FDA Announces Updates to Standards for Biologics

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In a Federal Register (FRN) notice, published on May 4, 2016, the Food and Drug Administration (FDA) announced that they will be updating outdated requirements and amending certain standards that relate to general biological products.

In 2011, FRN 13563 was published that tasked Agencies to review policies and standards that can be updated to a more productive structure. In response to this task and after reviewing, “FDA is revising the general biological products standards relating to dating periods and removing certain standard preparations and limits of potency.” It has been found that these changes will modernize outdated technology and eliminate redundant requirements, while still protecting public health.

The amendments to the Biological standards and updates will be effective beginning September 16, 2016. Comments on the rule must be received by July 18, 2016.

The Federal Register notice can be accessed at:

https://www.federalregister.gov/articles/2016/05/04/2016-10385/standard-preparations-limits-of-potency-and-dating-period-limitations-for-biological-products

Read more at expeditors.com

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2016 East Coast Trade Symposium

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On May 4, 2016 Customs and Border Protection (CBP) issued Cargo Systems Messaging Service (CSMS) #16-000876 announcing that the East Coast Trade Symposium, with a focus on “Trade’s Impact on American Health, Safety, and Economic Prosperity,” will be held in Arlington, Virginia on December 1-2, 2016.
It will also feature topics such as, “The Future of Trade from an International Perspective, North American Single Window Approach and Vision, and International Trade in the Next Five Years.”

Registration is now open on a first come, first served basis and space is limited.

Read more at expeditors.com

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Roadrunner Reports 2016 Q1 Results and Revises 2016 Guidance

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Cudahy, WI – May 4, 2016 – Roadrunner Transportation Systems, Inc. (NYSE: RRTS), a leading asset-light transportation and logistics service provider, today reported financial results for the three months ended March 31, 2016.

Revenues for the quarter ended March 31, 2016 decreased 4.8% to $465.6 million from $489.0 million for the same quarter in 2015. Operating income was $10.6 million, compared to $26.8 million for the prior year quarter.

Read more at www.rrts.com

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