manufacturing
FDA declares Novo Nordisk drug manufacturing plant non-compliant
A troubled contract manufacturing plant in Indiana recently acquired by Novo Nordisk is considered noncompliant with Food and Drug Administration standards, a serious designation that could further delay approval of drugs made at the facility, including some from Scholar Rock and Regeneron Pharmaceuticals. STAT previously reported that an FDA inspection of the plant over the […]
Trump’s order of signs in order to stimulate pharmaceutical manufacturing in the United States
In the midst of continuous anticipation on prices on pharmaceutical products, President Trump signed a decree designed on Monday to reduce regulatory obstacles and return faster than pharmaceutical companies to manufacture their products in the United States, the move also includes plans to exert more pressure on foreign drug manufacturers to comply with quality control […]