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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
Drug industry trade groups PhRMA and BIO expressed a strong distaste for the Trump administration’s strategy for tackling high drug prices by importing Canadian medicines, arguing that the plan would fail to lower costs and could put patients at risk. Read More
The FDA published a final guidance over the weekend on compounding alcohol-based hand sanitizers and said the agency will not take regulatory action against outsourcing facilities for regulatory violations for such products provided they include certain ingredients. Read More