Tag: Food & Drug Administration
FDA Goes After Unproven COVID-19 Antibody Tests
Companies selling tests will be required to submit data proving accuracy within next 10 days
FDA Issues Emergency Use Authorization for Remdesivir
Remdesivir can be administered intravenously to treat COVID-19 patients with severe disease
Test for COVID-19 Antibodies Approved by FDA
Test checks for protective antibodies in a finger prick of blood
FDA Pulls Heartburn Drug Zantac From Market
Withdrawal of ranitidine products means they will not be available either by prescription or OTC
FDA Grants First Approval of Convalescent Plasma Therapy in COVID-19 Patient
Houston Methodist first to receive eIND approval for convalescent plasma in individual patient
FDA Issues Safety Alert for COVID-19 Risk With Fecal Transplant
Studies have recently shown SARS-CoV-2 present in stool of infected patients, suggesting transmission risk
FDA Eases Access to Blood Plasma Treatment for COVID-19 Patients
Patients receive injections of blood plasma taken from people who have recovered
FDA: Insulin Among Drugs Transitioned to Biological Products
New regulatory pathway for biologic drugs allows for approval of biosimilars, interchangeable versions
FDA Bans Electrical Shock Devices Used on the Mentally Disabled
Ban takes effect 30 days after publication in the Federal Register
Medtronic MiniMed 600 Series Insulin Pumps Recalled
Medtronic has received 26,421 complaints about malfunctions in the recalled insulin pumps
