The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...

Deciding which risk to tolerate has long been the F.D.A.’s role, but rising external pressures are making that decision more ...

The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...

At the recent CBER agency workshop on cell therapies and tissue-based products, a few surprising ideas discussed could have ...

The FDA has relied on food companies for decades to determine whether their ingredients are safe. Some chemicals and ...