Exubera launch delayed until New Year
The most recent estimate of the Exubera (inhaled insulin) rollout has been delayed again, this time until January 2007, according to a Pfizer report. The company cites manufacturing issues in the scale-up process as the cause of the delay. This news follows speculation by some that the product may not become the blockbuster as originally touted, including a report in Business Week that cited Exubera's clunky, large-sized inhaler and required periodic lung function tests as reasons for doubt.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
