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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
Colorado — one of five states with drug importation plans in the works — has submitted its plan for importing prescription drugs from Canada to HHS for approval. Read More
Sponsors who fail to meet certain Risk Evaluation and Mitigation Strategy (REMS) requirements won’t face FDA action during the COVID-19 outbreak, the agency announced. Read More
President Trump has invoked the Defense Production Act in response to the growing coronavirus pandemic, enabling the federal government to order private industry to manufacture emergency medical supplies. Read More
Manufacturers need to provide two-week updates on any supply issues during the COVID-19 emergency and going forward, the FDA said in a new straight-to-final guidance. Read More
Researchers are “running out of funding fast, which means new developments may never reach clinical trials and, ultimately, achieve regulatory approval,” Wellcome Trust said. Read More