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The FDA has removed an Indian supplier of hydroxychloroquine and chloroquine APIs from an import alert to free up imports of the potential COVID-19 treatments from two of its plants. 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
State pharmacy boards in Idaho, Ohio, Nevada and Texas are restricting prescriptions of certain drugs that may hold potential in treating the coronavirus, including chloroquine and hydroxychloroquine, following a spike in demand. Read More
“There are many reasons that make demonstrating effectiveness extremely challenging” for drugs intended to treat such rare diseases, the agency said. Read More
The Medicines and Healthcare Products Regulatory Agency also said Friday that there is currently no research linking ibuprofen to the likelihood of contracting the virus or worsening the symptoms. Read More
Sponsors in the EU should conduct risk assessments of all trial procedures in the face of the COVID-19 outbreak, according to a guidance issued by the European Medicines Agency (EMA) on Friday that also suggests they should hold off on initiating trials or adding participants to current trials. Read More
The scheme involved the creation of compounded pain cream prescriptions and the billing of healthcare programs for injured state and federal workers. Read More
The FDA said it does not plan to object to delays in adverse event reporting for medical products during a pandemic, in a final guidance released yesterday. Read More