By Scott Gottlieb MD & Gerald Dal Pan MD, MHS – The US FDA is an information-driven agency that requires robust data to make regulatory decisions. One of our key obligations is to analyze large quantities of data related to the safety and effectiveness of medical products…
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By Anna Abram & Mark Abdoo – Even in this modern era, when so much can be done remotely, there are many tangible benefits to having “boots on the ground” when doing business overseas. That’s the thinking behind the FDA’s foreign offices, which play a vital role in inspecting….
By Scott Gottlieb, MD, Jeff Shuren, MD, JD, & Michelle Tarver, MD, PhD – Collaboration. It’s a word we use a lot at the FDA — and for good reason. Collaboration is an essential element of many approaches we apply to achieve our public health mission.
By Suzanne B. Schwartz – Ensuring medical devices are safeguarded from cyber intrusions is a shared responsibility across the medical device ecosystem. At the FDA, we deal with cybersecurity in the context of the total product lifecycle of a device.
By Jeff Shuren MD JD – FDA guidances explain the agency’s interpretation of, or policy on, a regulatory issue. The agency and its centers prepare guidances for industry, but also for other customers, including our own staff…
By Scott Gottlieb MD – When the FDA recently granted marketing authorization for two medical apps for Apple’s new Watch, it marked a significant step forward for the agency’s overall approach to the development of digital health.
By Scott Gottlieb MD – Advancing the public health means helping to make sure patients have access to safe, effective medical products. Access is a matter of public health. And our commitments to patients don’t stop at the time of a product’s approval.
By Scott Gottlieb MD – Over time, as our experience with new medical products expands, our knowledge about how best to maximize their benefits and minimize any potential risks, sharpens with each data point we gather.
By Christopher Leptak MD PhD – To be most effective, electronic health records use a systematized and standardized nomenclature for the hundreds of thousands of clinical terms that characterize patient care.