The FDA has launched a free mobile app version of its Drugs@FDA online database that offers consumers information on agency-approved drugs. The new app, called Drugs@FDA Express, is free and currently ...

Black box warnings are the FDA’s bluntest regulatory instrument short of a recall. Yet despite what headlines, pundits, and ...

The first-of-its-kind app to help you find out where your generic drugs come from and see the track records of the factories ...

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

This article presents an overview of FDA’s recent update to the guidance document, Control of Nitrosamine Impurities in Human Drugs. In September 2024, the much-anticipated update to FDA’s Guidance ...

The US Food and Drug Administration will take steps to streamline the development of generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to accelerate ...

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...

The Food and Drug Administration (FDA) recently approved a drug for smallpox — a disease that was eradicated nearly 40 years ago. On July 13, the agency announced it approved Tpoxx, the first drug ...

To hear health officials in the Trump administration talk, artificial intelligence has arrived in Washington to fast-track new life-saving drugs to market, streamline work at the vast, ...

Changes in U.S. Food and Drug Administration (FDA) procedures meant to speed approvals for medications may have resulted in less exacting standards, a new analysis suggests. Congressional acts that ...

Please provide your email address to receive an email when new articles are posted on . The FDA said it will send letters to pharmaceutical companies asking for the removal of “misleading” drug ads.