Tag Archives: FDA

“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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BIO Responds to GPhA Citizen Petition on Biosimilars Naming

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Last September, the Generic Pharmaceutical Association (GPhA) filed a Citizen Petition with the FDA, requesting the FDA to “implement its INN naming policy equally to all biologics” and to require “all biologics approved under the Section 351(k) pathway…share the same INN [International Nonproprietary Name] as the RPP [reference protein product]” (the GPhA Petition). Today, BIO submitted our response. Contrary to the GPhA Petition, BIO believes that the legal, regulatory, and scientific principles related to biologics and biosimilarity Read More >

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