A Look Back: The AIDS Crisis and FDA … 30 Years Later

By: Richard M. Klein The first patient-focused office at FDA – and very possibly the first patient engagement office in the federal government – was the Office of AIDS and Special Health Issues, established in 1994 at the height of … Continue reading →

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Building a Customized Plan to Help Ensure Food Safety

By: Jenny Scott Every day we evaluate potential hazards in our lives, and take steps to avoid them. We wear our seatbelts. We baby-proof our homes when we have young children. We use passwords to protect secure information online. You … Continue reading →

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FDARA: Making a Difference for Industry and Patients

By: Peter Marks, M.D., Ph.D., Jeffrey Shuren, M.D., J.D., and Janet Woodcock, M.D. For decades, user fees paid by the medical products industry have provided critical resources needed to conduct product reviews in a timely fashion and to help ensure … Continue reading →

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New System Speeds FDA Import Decisions

By: Douglas Stearn The data is in. A new automated system for determining whether FDA-regulated products can enter the United States is allowing us to make decisions faster and more efficiently. Quick admissibility decisions are critical to commerce, especially when … Continue reading →

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Patient Reps – Bringing the Voice of Patients to FDA

By: Jack Kalavritinos At FDA we never lose sight of the fact that the work we do in evaluating and approving new medical products is done to benefit patients. Increasingly, that means taking into account the views and expertise of … Continue reading →

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Dietary supplement concerns? Tell the FTC and FDA

By: Mary Engle, FTC, and Steven Tave, FDA Ever bought a dietary supplement or other health-related product that didn’t work as promised? Maybe you had side effects, or the claims just seemed unbelievable. Know this: the government holds companies accountable … Continue reading →

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