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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
The European Medicines Agency yesterday urged sponsors to do multi-center, multi-arm clinical trials to generate evidence on COVID-19 treatments, saying they’re most likely to generate the evidence needed to rapidly develop and approve treatments. Read More
President Trump yesterday promised in sweeping terms that the FDA will slash regulatory red tape to get COVID-19 therapeutics to patients as FDA Commissioner Stephen Hahn walked back some of Trump’s comments about what is realistic without jeopardizing patient safety. Read More
One bill would authorize $80 million from fiscal years 2021 to 2025 for the FDA to designate National Centers of Excellence in Continuous Pharmaceutical Manufacturing. Read More
Protocol changes and deviations may be unavoidable to ensure the safety of trial participants during the COVID-19 crisis, the FDA says in a rare direct-to-final guidance released yesterday, and sponsors and investigators should examine alternatives to face-to-face trial procedures. Read More
FDA Commissioner Stephen Hahn announced late yesterday that the agency has suspended routine domestic facility inspections in response to the COVID-19 outbreak. Read More
President Trump announced Wednesday that he is invoking 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