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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
Roche is making progress in efforts to repurpose its immunosuppressive drug Actemra (tocilizumab) for treating the coronavirus, gaining FDA approval for a phase 3 trial, the company announced Thursday. 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
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
With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior CDER official. 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