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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
Sponsors of drugs to improve glycemic control in patients with Type 2 diabetes should evaluate safety data from longer-term studies and consider patients with comorbid conditions, a new FDA draft guidance says. Read More
In a blow to Genentech’s blockbuster cancer drug Herceptin, a federal appeals court refused to temporarily suspend sales of Amgen’s biosimilar while a lower court considers a patent infringement challenge. Read More
Clinical trials of drug products intended for topical application should assess the risk of contact dermatitis, a new FDA draft guidance says. Read More
The FDA detailed how and when drug sponsors should evaluate the nonclinical toxicity of drug metabolites, in a final guidance released Friday. Read More