Tag Archives: FDA

Congress, Media Focused on Biotech Food Labeling

food label

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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Expanding the Role of Patients in Drug Development

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Working alongside scientists, universities, and biotech companies, patients and patient organizations have the ability to play a critical role in the search for treatments and cures for chronic and deadly diseases.  As part of the 5th authorization of the Prescription Drug User Fee Act (PDUFA V), the Food and Drug Administration made a commitment to more systematically gather patients’ perspectives on their condition and the available therapies in order to incorporate these findings into their Read More >

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BIO Is Almost Here – What To Consider Before Entering New Therapeutic Areas

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Over the past decade, the biopharmaceutical industry has witnessed a shift towards specialty care. From 2008 to 2014, FDA specialty drug approvals jumped from 33 percent to over 50 percent of all approvals. In 2014, the FDA approved a record 19 specialty care medicines. Given this new reality, companies are expanding the focus of their R&D into new therapeutic areas to address difficult-to-treat, specialty care conditions. Building successful franchises requires a strategic approach to determine the Read More >

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Biosimilars at the Federal Circuit – Can the Parties Be Compelled to Dance?

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In 2009, Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”), which for the first time provided for biosimilar or interchangeable biological drug products.  But it was not until March 6, 2015, that the FDA approved the first biosimilar application – an application by Sandoz to market a version of Amgen’s NEUPOGEN® (filgrastrim) biologic drug product.  Nevertheless, there is still a question as to when Sandoz will be able to begin selling its drug product, Read More >

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