BRUSSELS @ EU regulators and notified body representatives said their organizations are evaluating the use of artificial intelligence (AI) for regulatory purposes but cautioned that the technology is ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, ...

WASHINGTON, DC @ Despite the rapid changes happening at the US Food and Drug Administration (FDA), the Michelle Tarver, director of the Center for Devices and Radiological Health (CDRH), said the ...

Cancer medications that had their accelerated approval indications withdrawn by the US Food and Drug Administration (FDA), but were still on the market for another approved indication saw a decline in ...

Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. The Trump ...

The US Food and Drug Administration (FDA) has issued four warning letters to companies in China, India, and the US for various violations of good manufacturing practices (GMPs) related to the ...

The US Senate has confirmed President Donald Trump@s nominees to lead the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) in two votes split largely down party lines.

LINTHICUM HEIGHTS, MD @ The upheaval at the US Food and Drug Administration (FDA) under the Trump Administration has created significant uncertainty for healthcare product stakeholders, according to ...

US Food and Drug Administration (FDA) staff were ordered to return to their offices today, as the Trump administration has eliminated the ability of many federal employees to work remotely. Some ...

This program is open to students currently enrolled in university who do not receive employer support for travel. Previous participants in the Student Ambassador Program are ineligible to participate ...

The European Medicines Agency (EMA) and the European Medicines Regulatory Network are concerned that marketing authorization applications (MAA) are not being handled efficiently, leading to ...

The US Food and Drug Administration (FDA) has released a draft guidance outlining the purpose and content of a use-related risk analysis (URRA) for drug- and biologic-led combination products.