FDA clears a Spinal Simplicity 510(k) for the Patriot-SI Posterior Implant System as part of a hybrid sacroiliac joint fusion construct.
Federal Register notice: FDA makes available a draft guidance entitled Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public...
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Section 564 Declared E...
AdvaMed calls for updates to FDA and HHS informed consent guidances.
FDA approves Boehringer Ingelheims high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), an interchangeable biosimilar to Abbvies...
The National Community Pharmacists Association raises several categories of concerns with FDA in advance of the agencys annual drug compounding listen...
FDA publishes a guidance recognizing the latest revision of the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood ...
Federal Register notice: FDA publishes a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices und...
