The FDA Oncology Center of Excellence says it will mark its inaugural National Black Family Cancer Awareness Week 6/17-6/23.
HHS asks the DC federal court to dismiss a stakeholder suit seeking to bar the agency from implementing a Section 804 drug importation program.
Moderna begins a rolling BLA for its mRNA Covid-19 vaccine for use in individuals 18 years of age and older.
FDA posts a notice giving 6/24 as the effective date for certain specified OPDP submissions to be in the eCTD format.
FDA Review posts the Federal Register notices for the week ending 5/28/2021.
The U.S. Government Accountability Office says FDA should focus on reducing its inspections backlog, requesting the agencys plans to identify, analyze...
FDA issues Eton Pharmaceuticals a complete response letter on its NDA for dehydrated alcohol injection for treating methanol poisoning.
Federal Register notice: FDA revokes Battelle Memorial Institutes emergency use authorization for the Battelle Critical Care Decontamination System.