FDA warns Brea, CA-based Clinical Resources Laboratory about CGMP violations in its production of misbranded unapproved new drugs.
Attorney Bryan Feldhaus says the revised FDA intended use regulation clarifies but does not change the definition of intended use and should not adver...
FDA warns San Diego, CA-based Vitae Enim Vitae Scientific about repeat CGMP violations in its work producing finished drugs as a contract manufacturer...
The House Select Subcommittee on the Coronavirus Crisis is asking for an FDA briefing on the status of vaccination for children under age 5 and whethe...
Wilson and Sontini attorneys say the Department of Justice Consumer Protection Bureau featured FDA in its recent highlights report.
Federal Register notice: FDA withdraws the approval of 14 no-longer-marketed ANDAs from multiple applicants.
Federal Register notice: As part of FDAs ongoing Drug Efficacy Study Implementation, the agency announces that all outstanding hearing requests regard...
Student advocates from Universities Allied for Essential Medicines ask to meet with FDA commissioner Robert Califf on ways to improve clinical trial r...