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The draft guidance provides guidance on the development of drugs and biologics in which a nanomaterial is present in the finished dosage form.
On Dec. 15, 2017, FDA published draft guidance outlining the agency’s thoughts on the development of drugs and biologics that contain nanomaterials in the finished dosage form. Nanomaterials used in drug products may include inactive and active ingredients that may result in product attributes that differ from products that do not contain nanomaterials. Therefore, the agency feels these materials need particular examination.
The new guidance is one of several the agency has published related to nanotechnology. This guidance is targeted to applicants and sponsors of investigational, premarket, and postmarket submissions of products containing nanomaterials. It addresses “general principles and specific considerations for the development of drug products containing nanomaterials, including considerations for establishing the equivalence of such products with other drugs.”
The guidance provides a risk-based framework and discusses risk factors for these types of products. Chemistry, manufacturing, and controls regarding these products is also discussed, as well as environmental impacts.