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 → (Source: FDA Voice)
Source: FDA Voice - September 1, 2017 Category: American Health Source Type: blogs
New Steps To Strengthen FDA ’s Inspection And Oversight Of Drug Manufacturing
By: Scott Gottlieb, M.D. Manufacturing of drugs has become increasingly complex and global, requiring us to remodel our oversight of these tasks, to improve FDA’s efficiency and reach. As a step toward achieving these goals, FDA previously announced that we’re … Continue reading → (Source: FDA Voice)
Source: FDA Voice - September 1, 2017 Category: American Health Source Type: blogs
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 → (Source: FDA Voice)
Source: FDA Voice - August 22, 2017 Category: American Health Source Type: blogs
Working to Improve Information on Medication Use during Pregnancy
By: Pamela E. Scott, Ph.D. When women are pregnant they take care to eat right and refrain from smoking and drinking alcoholic beverages. But what to do about prescription drugs is a more complicated topic. There are very few prescription … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 22, 2017 Category: American Health Source Type: blogs
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 → (Source: FDA Voice)
Source: FDA Voice - August 21, 2017 Category: American Health Source Type: blogs
China Joins ICH in Pursuit of Global Harmonization of Drug Development Standards
By: Theresa M. Mullin, Ph.D. Increasingly, drug development is a global endeavor. It requires international collaboration to ensure that consistent standards are adopted and adhered to by all drug makers and regulatory authorities, regardless of country of origin or destination. … Continue reading → (Source: FDA Voice)
Source: FDA Voice - August 9, 2017 Category: American Health Source Type: blogs
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 → (Source: FDA Voice)
Source: FDA Voice - July 31, 2017 Category: American Health Source Type: blogs
FDA Announces New Steps to Empower Consumers and Advance Digital Healthcare
By: Scott Gottlieb, M.D. When people think about personalized medicine, they often think of genetic testing and sequencing of the human genome. But the concept of personalized medicine is much broader. It includes the re-imagination of healthcare delivery. It includes … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 27, 2017 Category: American Health Source Type: blogs
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 → (Source: FDA Voice)
Source: FDA Voice - July 26, 2017 Category: American Health Source Type: blogs
FDA Sets Inaugural Meeting of First-Ever Patient Engagement Advisory Committee
By: Kathryn O’Callaghan and Jeffrey Shuren, M.D., J.D. Imagine checking your blood sugar levels several times a day with a glucose meter to keep your diabetes under control. Or maybe you’ve had a hip joint replaced or a stent inserted … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 25, 2017 Category: American Health Source Type: blogs
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 → (Source: FDA Voice)
Source: FDA Voice - July 25, 2017 Category: American Health Source Type: blogs
The Expanded Access Navigator – Helping Patients In Need of Potentially Life-Saving Drug Treatments
By: Richard A. Moscicki, M.D. Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy and who seek access to potentially life-saving investigational drugs will have another option to guide them through the … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 24, 2017 Category: American Health Source Type: blogs
Keeping the U.S. Prescription Drug Supply Chain Among the Safest in the World
By: Ilisa Bernstein, Pharm.D., J.D. The U.S. prescription drug supply is among the safest in the world, but it can be challenging to keep it that way. Criminals – both here and abroad – constantly threaten to replace safe, effective, … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 20, 2017 Category: American Health Source Type: blogs
Leveraging FDA Resources to Encourage Students to Pursue STEM Careers
By: Richard Pazdur, M.D. When I was in high school, I spent summers working as a restaurant dishwasher, grocery store stock boy and gardener in northwest Indiana. The idea of spending those weeks learning about science and medicine would not … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 18, 2017 Category: American Health Source Type: blogs
Building a Strong FDA Workforce to Bring Scientific Advances to Patients
By: Scott Gottlieb, M.D. The key to FDA’s public health mission, and its ability to bring innovative new therapies to patients, is the technical, scientific, and clinical expertise of its people. As the products that we’re asked to review become … Continue reading → (Source: FDA Voice)
Source: FDA Voice - July 17, 2017 Category: American Health Source Type: blogs
