The FDA’s latest draft guidance on accelerated approval for new drugs, “Expedited Program for Serious Conditions—Accelerated ...

The FDA has responded to the increasing use of artificial intelligence (AI) in the discovery and development of drugs and biologics by publishing its first provisional guidance on the technology's ...

Eliminating this pathway would require companies wishing to introduce ingredients in foods to publicly notify the FDA of their intended use and submit the supporting safety data, the HHS said.

MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...