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An HHS audit of the Medicaid program in 2017 found that the federal government lost $1.3 billion in rebates involving 885 misclassified drugs over five years. Read More
Approved NDAs for certain biological products will be deemed to be biologics licenses under new FDA policies beginning March 2020, allowing the products to compete under the biosimilars pathway and potentially lower drug costs. Read More
A coalition of more than 200 healthcare advocacy and biopharma groups warned congressional leaders on Monday of unintended consequences of the Trump administration’s proposal to tie Medicare Part B drug prices to those of foreign countries. Read More
The lawsuit accused the defendants of product liability violations, breaches of contract and implied warranty, and fraudulent concealment, among other charges. Read More
The FDA hit Baxter with a Form 483 after multiple problems were discovered at its Valle del Cauca, Colombia facility during a June 4-8 inspection. Read More
In his second major pharma bill in as many weeks, Sen. Jeff Merkley (D-Ore.) introduced legislation to levy fees on opioid makers to cover the costs of addiction treatment. Read More
The FDA revised its recommendations on current good manufacturing practices for drug compounding outsourcing facilities, drawing a line between agency requirements for sterile and nonsterile drug products and outlining practices to protect against contamination. Read More