FDA’s Win-Win: More Comprehensive IND Safety Reports With Minimal Effort Due To Harmonization
New proposed rule calls for replacing US FDA’s current annual reporting requirements for INDs with a safety update report that is consistent the format and content of the development safety update report (DSUR) supported by the International Council of Harmonisiation.
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The US Food and Drug Administration has adopted a guideline by the International Conference on Harmonisation that describes the format, content and timing of a development safety update report (DSUR) for an investigational drug1,2.
Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings
Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.
First Humira biosimilar launches raise worries about holes in US health system that may let the brand product continue to dominate. If Humira biosimilars can’t get a strong foothold, reform to biosimilar policy for medicines reimbursed through the pharmacy benefit may be necessary if the US wants to rely on these products to bring down the cost of brand biologics.