Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

FDA 2025 pulmonology drug alerts, including drug approvals/warnings, vaccine approvals, and medical device recalls/updates.

The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...

But in the world of medical devices, these things often stay ... Cardiac devices dominate the list of reports to the Food and Drug Administration of deaths and injuries. Here are three devices ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

To address these shortages, the FDA has put measures into place, including expedited review processes and the use of enforcement discretion. The FDA also now requires manufacturers to give at least ...

His work will contribute to ongoing efforts by the FDA to ensure the safety and effectiveness of insulin pups, pacemakers, hospital imaging machines and other electronic medical devices.