Tag Archives: FDA

2015 FDA Approvals: Highest Levels in Over a Decade

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2015 was a blockbuster year for FDA approvals of novel new medicines, many of them for serious and life-threatening conditions. As Dr. John Jenkins of the FDA’s Center for Drug Evaluation and Research (CDER) notes in a recent blog post, “During this past year, we approved many new drugs to treat various forms of cancer, including four to treat multiple myeloma, and others to treat lung, skin, breast, brain, colorectal, and other cancers. We also Read More >

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The March of Genetic Food Progress

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You may already be familiar with Julie Kelly’s contributions to the Genetic Literacy Project but you may not know that she is a cooking instructor and food writer in Orland Park, Illinois. The Wall Street Journal recently published an opinion piece by Julie Kelly on how ‘Farmaceuticals’ and other GM products are slowly being approved, despite political scare campaigns. Ms. Kelly’s piece does a great job of arguing how genetic engineering has gradually overcome fear-mongering and false misrepresentation from those who Read More >

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“Please Wait a Few Moments While Your Pill Prints”

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Since the late 1980’s, innovators have dreamed of living in a world where science could develop anything they want simply by pressing “print.” 3D printing has evolved to create an array of medical applications from prosthetics to printed bones and tissues, and now—3D printed pills. Three days ago, the Food and Drug Administration approved Spritam, the first 3D-printed drug expected to hit the market by early 2016. It was developed by Ohio based Aprecia Pharmaceuticals Read More >

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Congress, Media Focused on Biotech Food Labeling

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Media coverage of the biotech food labeling debate is at a fever pitch as the Safe and Accurate Food Labeling Act (H.R. 1599) is poised to see action on the floor of the House of Representatives this week. Among the highlights: Charles Conner, former United States Deputy Secretary of Agriculture and current president and CEO of the National Council of Farmer Cooperatives wrote an op-ed in RollCall: GMOs have been around for decades, helping farmers Read More >

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FDA Acts on Biosimilars

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The Biologics Price Competition and Innovation Act (BPCIA) deferred to the Food and Drug Administration with regard to implementing the particulars of how the biosimilar approval pathway would be implemented.  The U.S. Food and Drug Administration has issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act.  The Guidances were expressly “draft” in nature, and were the subject of public hearings with the Agency welcoming Read More >

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