The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations ...

A lung biopsy involves the removal of tissue or growths from the lungs. A doctor will use special devices, such as a fine needle, to remove the sample. A lung biopsy can help diagnose lung ...

2 The draft guidance defines a biopsy as a procedure that acquires tissue from a trial participant as part of the clinical trial protocol. The draft guidance does not address the acquisition of ...