Leap Year
Experts have weighed in with their perspectives on anticipated challenges and opportunities anticipated for the pharmaceutical industry in 2024, in an article published by Pharmaceutical Technology. Thomas Hartman, President and CEO with ISPE, highlights the importance of communication between regulators and manufacturers.
Both the FDA and drug manufacturers will need to focus on earlier communication and collaboration to mitigate shortages and avoid facility shutdowns. This is especially true of generic manufacturers–many of which are either shifting from generic medicines because of a lack of profitability or closing down entirely. Alongside the FDA’s mobile app and web portal dedicated to reporting drug shortages, the introduction of new technologies in digital validation and data management will improve visibility within manufacturing and allow for early communication to the FDA regarding potential disruptions.
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