The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...

The FDA has set maximum levels for lead in baby food. A new California law requires baby food makers selling products in the ...

The US FDA has introduced voluntary guidelines on the level of lead content in processed baby foods sold in the country.

Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...

On Monday, the U.S. Food and Drug Administration (FDA) announced that, for the first time, it is setting guidelines for an ...

The U.S. Food and Drug Association (FDA) released the first-ever guidelines for levels of lead in processed baby foods this ...

The U.S. Food and Drug Administration released draft guidelines on Jan. 6 proposing that manufacturers conduct larger, ...

The FDA has released draft guidance for developers of AI-enabled medical devices, offering recommendations aimed at ensuring the safety and effectiveness of the devices.

The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...

The US Food and Drug Administration has issued guidance urging sponsors and trial sites to consider the necessity of the ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...