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“The ever-increasing expenses associated with the legal and regulatory compliance for this segment of drugs are simply not sustainable,” the company said. Read More
In a final guidance, the FDA outlined the new structure of the user fee program under the Biosimilar User Fee Act of 2017 (BSUFA II) which eliminated certain fees and extended the agency’s authority to collect fees through fiscal 2022. Read More
Janssen made the observation in one of 19 letters filed in response to a request for comments on how OND could promote effective drug development programs. Read More
Rochester Drug Co-operative, one of the country’s top ten drug distributors, is pulling the plug on its opioid distribution operations after running into serious legal and regulatory troubles. Read More
Eli Lilly plans to launch two new cheaper insulin products amid criticism about the availability of its lower-cost insulins on pharmacy shelves. Read More