[ Price : $8.95]
FDA grants a de novo marketing authorization to Cepheid for its Xpert HCV test and GeneXpert Xpress System for detecting hepatitis...[ Price : $8.95]
FDA publishes a guidance to help sponsors pursue Priority Zoonotic Animal Drug designation for a new animal drug.[ Price : $8.95]
FDA publishes a draft guidance on the content and format of certain diversity action plans intended to increase clinical study enr...[ Price : $8.95]
FDA approves a Verona Pharma NDA for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disea...[ Price : $8.95]
BrainStorm Cell Therapeutics says it has reached alignment with FDA on chemistry, manufacturing, and controls aspects of the compa...[ Price : $8.95]
CDRH says it is partnering with the Bill and Melinda Gates Foundation and the National Institute for Standards and Technology on a...[ Price : $8.95]
Federal Register notice: FDA submits to OMB a proposed information collection entitled Voluntary Total Product Life Cycle (TPLC) A...[ Price : $8.95]
Federal Register notice: FDA requests comments on its Information Technology Strategy and Customer Experience Strategy.