Drugs containing nanomaterials: FDA finalizes 2017 guidance with several changes
The FDA on Thursday finalized a draft guidance from 2017 explaining the principles and specific considerations for developing drugs (biologics and gene therapies are excluded) containing nanomaterials, including via abbreviated pathways.
Considerations related to quality, nonclinical, and clinical studies are included in the 29-page final guidance, which also features “two noteworthy changes” from the draft version in response to stakeholder comments, according to the FDA.
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