For certain bespoke therapies, the current regulatory exemption from good manufacturing practices requirements for Phase I investigational new drug products will only apply to the first batch, the US Food and Drug Administration explains in 7 December draft guidance.
US FDA Limits GMP Exemption For ‘N of 1’ Investigational New Drugs
Agency drafts guidance on how to apply requirements for chemistry, manufacturing and controls, and for good manufacturing practices, to bespoke antisense nucleotides.
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