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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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The Dangers of Being Misinformed: Latest Measles Outbreak

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USA Today covered the latest measles outbreak in today’s print edition (see story: Texas Measles Outbreak Linked to Church).  Since measles is still common in many parts of the world, travelers can bring it into the country and infect adults and children who have not been vaccinated. This latest outbreak resulted when a visitor to Eagle Mountain International Church in Newark, Texas spread the disease to other members and visitors of the church after contracting Read More >

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Involving Patients in the Research Process

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According to the National Psoriasis Foundation, as many as 7.5 million Americans live with psoriasis, making it the most common autoimmune disease in the country. More than just a skin condition, psoriasis puts people at increased risk for other serious diseases such as heart disease, diabetes and depression. Up to 30 percent of people with psoriasis develop psoriatic arthritis, an inflammatory joint disease. A complex disease with a genetic component, psoriasis is not contagious. While Read More >

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GAINing Ground in Antibiotics

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With the rise of antibiotic resistant “superbugs” in recent years, everyone agrees there is an urgent need to develop new and effective antibiotics. One measure designed to spur such development is the Generating Antibiotics Incentives Now (GAIN) Act, which was enacted last year. The law provides an additional five years of market exclusivity and priority FDA review for innovative antibiotics that target qualifying pathogens. Much of the current research in the field is being done 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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