Category Archives: Health

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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 The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods.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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Back to School: Time for Immunization Check-In

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Preparing for school means gathering supplies and backpacks. It is also the perfect time to make sure children are up-to-date on their vaccines. Getting all of the recommended vaccines is one of the most important things parents can do to protect their children’s health. Vaccines are among the safest and most effective ways to prevent disease. Protecting your child from preventable diseases will help keep them healthy and in school. But vaccines don’t just protect Read More >

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How the Orphan Drug Tax Credit Leverages MDA’s Fight against Rare Genetic Diseases

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In the early 1950s, a small group of concerned parents, people with muscular dystrophy and their friends started a volunteer organization, the Muscular Dystrophy Association (MDA), to raise money for research into the causes of rare genetic diseases that mysteriously destroyed muscles and shortened lives. In the decades since — thanks to the support of a caring public and vital corporate partnerships — MDA has become a leading voluntary health agency, funding research in academic Read More >

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