Tag Archives: FDA

FDA Consumer Update: Advances in Saving Lives with Blood

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Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of all ages who are injured, need surgery or who are suffering from illness. The Food and Drug Administration’s primary responsibility with regard to blood and blood products is to assure the safety of patients who receive these life-saving products. In this interview, Richard Davey, M.D., director of the Division of Blood Applications, Office of Blood Research and Review at FDA Read More >

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New FDA Final Guidance on Clinical Trial Institutional Review Boards

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On Tuesday, August 27th, the FDA finalized its Guidance for Institutional Review Boards, Clinical Investigators and Sponsors on Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed.  In an article published earlier today, the Pink Sheet’s Sarah Karlin summarized the goals of this guidance as strengthening human subject protection during clinical research and increasing the efficiency of Read More >

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FDA Issues Final Guidance on Clinical Trial Oversight

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The FDA released its final guidance governing clinical trial oversight and urges a risk-based approach to monitoring. The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods. The guidance provides various risk-based monitoring strategies and clarifies that while the Sponsor can transfer monitoring responsibilities to contract research organizations (CROs), the CROs Read More >

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What OxyContin Tells Us About the Value of “Evergreening” and Patents

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A few weeks ago, the  FDA announced that they would not allow generic versions of older versions of OxyContin. The original formulation of OxyContin goes off patent today. The original formulation did not have “tamper-resistant qualities” that prevent people from “crushing, breaking, and dissolution using a variety of tools and solvents.”  The article reports that the decision will keep Teva Pharmaceuticals and Impax Laboratories from making the older version which the FDA has determined is too dangerous Read More >

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Legislative Hopes, Fears

PNNL Research Scientist Heather Brown

Biotechnology advances are poised now more than ever to help policymakers achieve their goals of supporting innovation in health care, renewable energy, and green technologies. How can they help us? Here are our six hopes (and one big concern) for the term ahead. HOPE 1: Cultivate an atmosphere for patient access to our products While the Congress considers finding savings, do it in a way that does not threaten patient access to drug products by Read More >

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