Tag Archives: FDA

BIO Calls on Appropriators to Fully Fund FDA

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BIO issued letters today encouraging support for programs and initiatives of critical importance to our industry as appropriators develop the Fiscal Year 2015 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations Act. Perhaps most importantly, we emphasize the importance of a strong, fully-funded FDA with the resources necessary to keep pace with rapidly-evolving biomedical science and to make sound regulatory decisions in a timely and efficient manner. We are requesting a total Read More >

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“No Need to Label GMOs” Says FDA

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The Nation’s Leading Regulatory Body on Food Safety Reaffirms Safety of GMOs On March 28, 2014, the Food and Drug Administration Commissioner Margaret Hamburg testified to the House Appropriations Committee on the FDA’s 2015 budget request. In a line of questioning, she was asked about the labeling of GMOs. The Hill’s Benjamin Goad tracked her response reaffirming that the FDA will not label GM foods. “Margaret Hamburg told lawmakers this week that the agency remains Read More >

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FDA: Vaccines a Critical Tool in Protecting and Promoting Public Health

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Yesterday, Dr. Karen Midthun of the FDA wrote about the important role of vaccines in promoting public health: Vaccines are a critical tool in protecting and promoting the public health in the U.S. and around the world. The risks from childhood diseases like measles, mumps and polio have been greatly reduced, or in the case of polio, eliminated in the U.S. Vaccines are one of the great public health success stories of the 20th century. Dr. Midlun Read More >

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U.S. Rep. Charlie Dent Discusses PDUFA and NIH Funding at #BIOCEO14

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During the 16th Annual BIO CEO & Investor Conference, U.S. Representative Charlie Dent of Pennsylvania, co- chair of the Congressional Biomedical Research Caucus, joined BIO’s Fritz Bittenbender to discuss the biotech industry in Pennsylvania as well as recent legislative developments affecting the industry. Dent points to the recent omnibus spending agreement which allowed the Food and Drug Administration (FDA) to access user $85 million in user fees sequestered in 2013. These fees are paid to Read More >

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4 Tips for Building a Successful Biotech: Richard Pops of Alkermes at #BIOCEO14

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The 16th Annual BIO CEO & Investor Conference opened with a fireside chat between Richard F. Pops, Chairman & Chief Executive Officer of Alkermes, and David Gluckman of Lazard. The candid discussion gave biotech CEOs a peek in to the story of Alkermes, yielding useful guidance on building a successful, agile company ready for a changing marketplace. Here are some of the highlights: Be world class in a specific area of science. “In our company, Read More >

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