FDA warns DeChoker about Quality System regulation violations in its production of a tracheobronchial suction device.
Federal Register notice: FDA determines that Novartis Sandostatin (octreotide acetate) injection was not withdrawn for safety or effectiveness reasons...
FDA issues a safety communication warning against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibod...
Greenlight Guru founder Jon Speer says medical device companies should use a quality management system solution to maintain closed-loop traceability a...
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.