RAPS

FDA finalizes certificates of confidentiality guidance

The US Food and Drug Administration (FDA) finalized its guidance explaining how sponsors can request certificates of confidentiality (CoC) meant to protect the privacy of clinical trial participants. ...
RAPS

Export Certificates for Devices: FDA Issues Draft Guidance

The US Food and Drug Administration (FDA) on Thursday released new draft guidance to explain the process by which persons can be denied a Certificate to Foreign Government (CFG) for a device and what ...
Politifact

A product says it's ‘FDA approved,’ ‘FDA registered’ or ‘FDA certified.’ What does that even mean?

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.