CDER launches a task force to assess and improve the Center workplace culture in terms of harassment, bullying, and civility.
Hogan Lovells attorneys review the changes in a new FDA draft guidance on the Special 510(k) Program.
Federal Register notice: FDA makes available a draft guidance entitled Assessing the Irritation and Sensitization Potential of Transdermal and Topical...
Federal Register notice: FDA publishes a list of information collections that have been recently approved by OMB.
Federal Register notice: FDA makes available a revised draft guidance entitled Assessing Adhesion With Transdermal and Topical Delivery Systems for AN...
Three Democratic senators led by presidential hopeful Elizabeth Warren raise concerns about CDRHs regulation of digital health devices and the Centers...
Members of the FDA Oncologic Drugs Advisory Committee vote unanimously to recommend approval of a Celltrion biosimilar to Biogens Rituxan for three ca...