We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Chalker and his co-conspirators operated a nationwide telemarketing and telemedicine scheme that did not provide actual patient care and had no patient-prescriber relationships. Read More
The International Federation of Pharmaceutical Manufacturers & Association last week called for a global ban on gifts and promotional aids for prescription drugs in any country its members operate. Read More