LifeVac is approved for use as a single-use, non-powered, non-invasive airway clearance device.

The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...

LifeVac has picked up a groundbreaking clearance from the FDA for its suction-powered device designed to dislodge an object ...

The FDA's decision on a chatbot for patients recovering from surgery could offer clues on how the agency plans to regulate ...

As 2025 draws to a close, the state of the federal system of regulatory affairs in the United States continues to operate in a somewhat chaotic fashion. FDA has perhaps been most affected by changes ...

The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling ...

The US Food and Drug Administration (FDA) has chosen to axe its ‘Final Rule’ from May 2024, bringing to an end a long-running agency-industry dispute around the proposed classification of ...

Mosaic expects the collaboration with the FDA will help address diagnostic capacity constraints in the US healthcare system.

During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a ...

(I would like to thank Leah Kendall of EpsteinBeckerGreen and Dane Stout of the Anson Group for their comments on a draft. The views expressed, right or wrong, are only the author’s and should not be ...

The Food and Drug Administration (FDA) regulates medications, medical devices, foods, cosmetics, certain electronic devices, pet and livestock products, and tobacco products. FDA regulation involves ...