House Select Subcommittee on the Coronavirus Pandemic Republican leaders ask FDA for communications and interviews relating to potential political int...
Four stakeholders provide additional information to the U.S. Patent and Trademark Office about its collaboration with FDA.
FDAers in CDER and the Oncology Center of Excellence discuss the use of minimal residual disease (MRD) data in hematologic clinical trials and treatme...
Servier says a Phase 3 clinical trial assessing glioma drug vorasidenib met its primary and secondary endpoints.
A former Becton Dickinson medical director petitions FDA to scrutinize the companys 2017 510(k) clearance for the GalaForm 3D due to label misreprese...
FDA announces a 5/2 Webcast entitled Navigating the First ICH Generic Drug Draft Guideline M13A Bioequivalence for Immediate-Release Solid Oral Dosag...
FDA warns Chatsworth, CA-based Formology Lab about CGMP violations in its production of drugs as a contract manufacturer.
FDA warns Houston, TX- based Dr. Maggie Jeffries/Avanti Anesthesiology about conducting a clinical investigation without a required IND.
