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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 The Agency builds on the main tenets described in the original 2011 draft guidance, urging drug and medical-device sponsors to utilize more remote and targeted risk-based monitoring rather than relying solely on on-site methods.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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Amid Doping Scandals, Industry Must Remain Vigilant

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As doping in sport makes its way back into the news of the day, we must consider the consequences beyond undermining the integrity and honor of sports and competition. Doping undermines the integrity of our industry’s core mission of serving patients through drug discovery and development. Biologic products intended for use as medicines can enhance endurance, minimize recovery time, or promote muscle growth. The same medicines that can be used to help children with devastating Read More >

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How Do Patients Get Their Medicines During Hurricanes?

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Hurricane season has grown to last six months – running June through November. This means we are well into 2013′s hurricane season. Although the Eastern and Southern United States have seen their fair share of bad storms in the last few years, the most recent major hurricane to strike the U.S. was Hurricane Wilma in 2005. Surprisingly Hurricane Sandy in October of 2012 was not technically was not a hurricane, but a confluence of major Read More >

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