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Within weeks of the approval of Pfizer’s biosimilar in 2016, J&J implemented a plan to maintain its market share, according to the complaint. Read More
The labeling includes specific U.S. rates for acute pancreatitis, spontaneous hyperinflation, gastric and esophageal perforation and aspiration. Read More
The agency advised that complete test reports are not necessary for special 510(k)s or for tests which have been provided a declaration of conformity to an appropriate agency-recognized consensus standard. Read More