Two Hyman, Phelps attorneys explain the orphan drug designation issues facing FDA in light of appeals court decisions against the agency.
Federal Register notice: FDA corrects a notice in the 6/25 Federal Register that announced the approval withdrawal of 36 ANDAs from multiple applicant...
Federal Register notice: FDA seeks comments on an information collection extension entitled Obtaining Information to Understand Challenges and Opportu...
Federal Register notice: FDA sends to OMB an information collection extension entitled Electronic User Fee Payment Request Forms Form FDA 3913 and Fo...
Generic drug makers Taro Pharmaceuticals, Sandoz and Apotex agree to pay $447 million to resolve alleged False Claims Act violations related to price ...
A new FDA final rule on the medical device de novo marketing pathway clarifies earlier language contained in the proposed rule to now permit manufactu...
Federal Register notice: FDA announces that 23 information collections have been approved by OMB.
Teva Pharmaceuticals temporarily stops production at its Irvine, CA manufacturing facility after a recent FDA inspection cited manufacturing concerns ...