The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

This week in Pedersen's POV, our senior editor argues against FDA's huge shift in digital health — made without public ...