As part of the Trump Administration’s all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments.

The FDA is facilitating access to convalescent plasma, antibody-rich blood products that are taken from blood donated by people who have recovered from the COVID-19 virus, that could shorten the length, or lessen the severity, of the illness. The agency will be using multiple pathways to support these efforts and has posted information for investigators wishing to study convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications for individual patients.

The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary.

The U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued warning letters to seven companies for selling fraudulent COVID-19 products. These products are unapproved drugs that pose significant risks to patient health and violate federal law.

The U.S. Food and Drug Administration approved Isturisa (osilodrostat) oral tablets for adults with Cushing’s disease who either cannot undergo pituitary gland surgery or have undergone the surgery but still have the disease. Cushing’s disease is a rare disease in which the adrenal glands make too much of the cortisol hormone.

The U.S. Food and Drug Administration has approved an application for the first generic of Daraprim (pyrimethamine) tablets for the treatment of toxoplasmosis (an infection caused by the parasite Toxoplasma gondii) when used with a sulfonamide (a group of medicines used to treat bacterial infections).

The U.S. Food and Drug Administration today announced that its first bilateral enforcement operation with the Government of India, stopped approximately 500 shipments of illicit, and potentially dangerous, unapproved prescription drugs and combination medical devices from reaching American consumers over the course of an operation that took place in January.