The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

Given the anticipated increase in demand for chloroquine phosphate and hydroxychloroquine sulfate, the FDA is taking steps to ensure that adequate supply of these drug products is available for patients:

Today, the FDA published product-specific guidances (PSGs) to support generic drug development for these drugs. The new PSG for chloroquine phosphate clarifies that the product is AA rated in the Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), meaning that there are no known or suspected bioequivalence problems, and no in vivo studies are necessary. The revised PSG for hydroxychloroquine sulfate adds advice about a Biopharmaceutics Classification System-based biowaiver option.

The FDA is currently prioritizing review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate under MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.

The FDA issued a Consumer Update: How You Can Make a Difference During the Coronavirus Pandemic. It explains ways to help, such as donating blood, protecting yourself and others, saving protective equipment for front line workers and reporting fraudulent products to the agency.

The FDA issued an Emergency Use Authorization (EUA) for the emergency use of the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES ("B. Braun Space and Outlook Pumps") for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and decrease the exposure of healthcare providers to such patients during the COVID-19 pandemic. The EUA was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.

The FDA issued an Emergency Use Authorization (EUA) to Advanced Sterilization Products, Inc. (ASP) for the ASP STERRAD Sterilization Systems that has the potential to decontaminate approximately 4 million compatible N95 or N95-equivalent respirators per day in the U.S. for single-user reuse by health care workers in hospital settings. This authorization is intended to help increase the availability of respirators so health care workers on the front lines can be better protected and provide the best care to patients with COVID-19.

Diagnostics update to date:
During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
To date, 34 emergency use authorizations have been issued for diagnostic tests.

The World Bank’s Board of Executive Directors today approved the $128.6 million Sri Lanka COVID-19 Emergency Response and Health Systems Preparedness Project to help the country prevent, detect, and respond to the COVID-19 pandemic and strengthen its public health preparedness.

The new fast track package will benefit the entire Sri Lankan population and prioritize stopping or slowing the spread of the virus, reducing case numbers, and preventing outbreaks in communities. This support will scale up emergency response mechanisms, strengthen the capacity of laboratories and hospitals, treat patients, train medical staff, and raise public awareness about handwashing, hygiene, and social distancing.

“The World Bank is working closely with the Government of Sri Lanka to contain the spread of COVID-19 and prepare the country for potential future disease emergencies,” said Idah Z. Pswarayi-Riddihough, World Bank Country Director for Maldives, Nepal, and Sri Lanka. “Sri Lanka has already taken preventive measures to contain this rapidly evolving pandemic and protect its people. Our support will complement these efforts and help reduce future risks.”

The project includes a $35 million loan from the International Bank for Reconstruction and Development (IBRD) through the World Bank Group’s COVID-19 Fast-Track Facility and a $93.6 million credit from the International Development Association (IDA), the World Bank’s concessional credit window for developing countries. The Ministry of Health and Indigenous Medical Services will implement the project with support from United Nations agencies and other stakeholders engaged in emergency response, prevention, and readiness

Through this project, the Government of Sri Lanka will be better equipped to respond to emergencies and strengthen existing institutions such as the National Institute of Infectious Diseases, which is now Sri Lanka’s only available medical facility outfitted for suspected and confirmed COVID-19 cases.

In addition, the first Bio Safety Level 3 laboratory will be developed at the National Medical Research Institute, Sri Lanka’s premier biomedical research center and main laboratory for virology, bacteriology, and parasitology.

World Bank Group COVID-19 Response

The World Bank Group is rolling out a $14 billion fast-track package to strengthen the COVID-19 response in developing countries and shorten the time to recovery. The immediate response includes financing, policy advice and technical assistance to help countries cope with the health and economic impacts of the pandemic. The IFC is providing $8 billion in financing to help private companies affected by the pandemic and preserve jobs. IBRD and IDA are making an initial US$6 billion available for the health-response. As countries need broader support, the World Bank Group will deploy up to $160 billion over 15 months to protect the poor and vulnerable, support businesses, and bolster economic recovery.