Home Tags Food & Drug Administration

Tag: Food & Drug Administration

The U.S. Food and Drug Administration has sent warning letters to seven companies for illegally selling products they claim will cure

FDA Warns Companies Illegally Selling Hangover Cures

People should be wary of any products that claim to prevent, treat, mitigate, or cure diseases
The permanent birth control device Essure is associated with higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding compared with tubal ligation

Higher Rates of Pain, Bleeding Found With Essure Birth Control Device

In 2018, Essure maker Bayer pulled the device from the U.S. market due to concerns about side effects
The U.S. Food and Drug Administration said Monday it will crack down on the fraudulent COVID-19 antibody tests that have flooded the market.

FDA Goes After Unproven COVID-19 Antibody Tests

Companies selling tests will be required to submit data proving accuracy within next 10 days
The U.S. Food and Drug Administration has granted an emergency use authorization for remdesivir to treat hospitalized patients with suspected or confirmed COVID-19

FDA Issues Emergency Use Authorization for Remdesivir

Remdesivir can be administered intravenously to treat COVID-19 patients with severe disease
The first COVID-19 virus antibody test for use in the United States has been approved by the Food and Drug Administration.

Test for COVID-19 Antibodies Approved by FDA

Test checks for protective antibodies in a finger prick of blood
All versions of the heartburn drug Zantac (ranitidine) have been pulled from the U.S. market due to possible contamination with a probable human carcinogen

FDA Pulls Heartburn Drug Zantac From Market

Withdrawal of ranitidine products means they will not be available either by prescription or OTC
Over the weekend

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
The U.S. Food and Drug Administration issued a MedWatch Safety Alert on Tuesday about the potential risk for SARS-CoV-2 transmission with the use of fecal microbiota for transplantation to treat Clostridioides difficile infection.

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
Access to a blood plasma treatment for seriously ill COVID-19 patients has been made easier by the U.S. Food and Drug Administration.

FDA Eases Access to Blood Plasma Treatment for COVID-19 Patients

Patients receive injections of blood plasma taken from people who have recovered
Insulin and other biologic drugs

FDA: Insulin Among Drugs Transitioned to Biological Products

New regulatory pathway for biologic drugs allows for approval of biosimilars, interchangeable versions