Benjamin England, Founder and CEO of Maryland-based FDA consulting firm, FDAImports.com, will present at the 2013 Boston Seafood Show as part of a Panel Discussion entitled, “Seafood Safety and Compliance with FDA and CBP Regulations as Implemented by the Food Safety Modernization Act.”  Mr. England will join other panelists, Peter Quinter of Gray Robinson, William Scopa of U.S. Customs and Border Protection (CBP), and John Verbeten of the U.S. Food and Drug Administration (FDA), in discussing specific concerns for the seafood industry within the Food Safety Modernization … READ MORE

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The U.S. Food and Drug Administration (FDA) has extended the registration renewal deadline for medical device establishments from Dec. 31, 2012 to Jan. 31, 2013. In addition, FDA has been drastically overloaded and delayed in responding to communications from the extra MDUFA III requirements this year and is asking industry to allow two weeks for responses. FDA is also rolling out a new online registration and listing platform.

Background
The Food and Drug Administration Safety and Innovation Act (FDASIA), passed in July 2012, is intended to help increase … READ MORE

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FDA’s quest for an increased budget and resources continues, as evidenced by its recently released FY 2013 Budget request. As FDA Commissioner Margaret Hamburg noted in her statement before the Committee on Appropriations, FDA believes that it’s bridging the gap between budget and its ever-increasing responsibilities. As the agency attempts to launch new procedures and regulations in coming years, a primary source of funding will be from user fees, according to the justification set forth.  It’s not that FDA is unfamiliar with user fees … READ MORE

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