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Novo Nordisk will cut the U.S. list price of multiple insulin products by up to 75 percent, following rival Eli Lilly’s announcement of a similar price cut earlier this month.
The Biden administration has asked Congress for almost $200 million in additional FDA funding for fiscal 2024 to enhance medical product safety and an extra $105.3 million to fully fund increases in the agency’s employee pay.
Formology Lab of Chatsworth, Calif., earned an FDA warning letter for failing to verify the identity of each component of a drug product, having no written procedures for process or production control as well as not having established an adequate quality control unit, among other serious lapses.
The FDA outlined its current thinking for drug sponsors on assessing gastric pH-dependent drug-drug interactions (DDI) in a final guidance released Monday.