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Sponsors should discuss their enrollment goals with sites and investigators to achieve greater participation of elderly patients, the agency said. Read More
The FDA spelled out the conditions under which it will not take action when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. Read More
The Trump administration’s plan for importing drugs from Canada will not result in lower prices for Americans, according to a slew of comments from drugmakers, industry groups and the Canadian government on the FDA’s proposed rule. Read More
A federal jury in Houston, Texas found a drug compounder guilty of billing the federal government more than $20 million for unnecessary compounds. Read More
President Trump sent a list of “principles” to lawmakers this week, outlining what the administration wants to see in a drug pricing bill as a Senate bill with some of the president’s ideas moves toward passage this spring. Read More
The Centers for Medicare and Medicaid Services (CMS) unveiled a model program that will cap Medicare Part D out-of-pocket insulin costs for seniors at $35 per month, and all three manufacturers for the U.S. market — Eli Lilly, Sanofi and Novo Nordisk — said they will take part. Read More
Hahn said that the agency hasn’t had time to check yet whether the APIs from India are used in the 20 drugs the agency identified as being at-risk for shortages. Read More
Colorado — one of five states with drug importation plans in the works — submitted its plan for importing prescription drugs from Canada to HHS for approval yesterday. Read More
FDA Commissioner Stephen Hahn announced yesterday that the agency has suspended most foreign inspections through April in response to the COVID-19 outbreak. Read More