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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
Electrical shock devices used to reduce aggression and self-harm in patients with autism and other developmental disabilities will be banned

FDA Bans Electrical Shock Devices Used on the Mentally Disabled

Ban takes effect 30 days after publication in the Federal Register
More than 322

Medtronic MiniMed 600 Series Insulin Pumps Recalled

Medtronic has received 26,421 complaints about malfunctions in the recalled insulin pumps
Compliance with the U.S. Food and Drug Administration Amendments Act of 2007 is low

Fewer Than Half of Clinical Trials Comply With Reporting Laws

Compliance with Food and Drug Administration Amendments Act of 2007 low, not improving
The U.S. approval and regulation processes for pharmaceutical agents have evolved during the last four decades

Evolution of Approval, Regulation Processes for Drugs Explored

FDA drug review times down from 1983 to 2017, but time from clinical testing to approval did not change
The U.S. Food and Drug Administration on Tuesday approved the sale of two reduced-nicotine cigarettes.

FDA Approves Sale of Low-Nicotine Cigarettes

Nicotine content of the two newly approved cigarettes is less than 1 mg per cigarette
Stephen Hahn

Hahn Confirmed as New FDA Chief

One major challenge facing Hahn is the teen vaping epidemic
Dollar Tree has been sent a warning letter for selling over-the-counter drugs made by foreign companies with serious

FDA Sends Warning Letter About OTC Drugs to Dollar Tree

Letter outlines corrective actions company needs to take, including ensuring they do not import impure drugs