“Achieving FDA 510 (k) clearance for IVD CAPSULE PSP marks a significant milestone for Abionic and confirms our ability to meet the need for quick & reliable sepsis testing,” said Patrick ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to ...

WASHINGTON (TNND) — The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10-12 months ...

The exterior of the Food and Drug Administration headquarters is seen on July 20, 2020 in White Oak, Maryland. This story was originally published on BioPharma Dive.

The FDA has released a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices, according to an FDA news release. The guidance is meant to ...