FDA approves a Medtronic PMA for In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions up to 360mm in patients with per...
FDA Rejects Pfizer Herceptin BiosimilarFDA has sent Pfizer a complete response letter on its BLA for the companys proposed trastuzumab biosimilar, a c...
Fresenius-Kabi USA begins a mandatory software update field action for the DXT Relay 2.x because of issues identified in the software that cause it to...
FDA Review posts the Warning Letters for the week ending 4/20/2018.
The Senate Homeland Security and Government Affairs Committee asks FDA for information on its policy to ask Imodium manufacturers to limit packaging s...
Federal Register notice: FDA makes available a final guidance entitled Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: ...
As part of its ongoing efforts to address the opioid epidemic, FDA releases a draft guidance to help sponsors develop medication-assisted treatments a...