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FDA Commissioner Stephen Hahn said the agency is meeting its user fee-related review goals for now as the COVID-19 outbreak rages, but the agency may not be able to sustain its current workload. Read More
The European Union has drafted a resolution calling on the World Health Organization to create a shared pool of intellectual property rights for vaccines and treatments during the coronavirus pandemic. Read More
Novo Nordisk yesterday offered free insulin for 90 days to patients who have lost their healthcare benefits because of the COVID-19 pandemic. If a patient’s Medicaid benefits are denied, assistance can be extended until the end of the year, the company said. Read More
The EMA said it will allow firms struggling to meet quality requirements when they increase manufacturing capacity to meet demand during the COVID-19 pandemic to use a risk-based approach. Read More
Researchers planning trials on the use of convalescent blood plasma to treat COVID-19 must submit an investigational new drug (IND) application, according to a new FDA final guidance that will remain in effect only for the duration of the public health emergency. Read More
Clinical trials should use the traditional IND process and provide evidence that the plasma to be used will be obtained from an FDA-registered blood establishment. Read More
Rep. Diana DeGette (D-Colo.) has called on the FDA to ensure that supplies of hydroxychloroquine and chloroquine are saved for approved indications, citing reports of hoarding. Read More
A group of more than 30 consumer, health and trade organizations urged three dozen countries — including the U.S. — to allow imports of drugs manufactured under government-issued patent exemptions during the COVID-19 crisis. Read More
The Drug Enforcement Administration (DEA) is allowing increased production and importation of some controlled medicines to address the surge in demand for drugs needed for COVID-19 patients on ventilators. Read More