title: Nanotechnology and therapeutic delivery: a drug regulation perspective.
abstract: Nanotechnology is expected to contribute to the therapeutic delivery field in the coming decade. Although the US FDA has multiple guidance documents in place to deal with novel drug products, nanoparticles may produce issues that have not been previously encountered with small drug molecules. This regulatory focus highlights some current guidance documents and thinking of the FDA as applied to nanoparticles used for therapeutic delivery.
authors: Center for Drug Evaluation & Research, US FDA, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA.
authors: Nakissa
authors: N
authors: Sadrieh
authors: Katherine M
authors: KM
authors: Tyner
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004337:Drug Carriers / Q000592:standards; D004339:Drug Compounding; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug / Q000592:standards; D053758:Nanoparticles / Q000592:standards; D036103:Nanotechnology / Q000331:legislation & jurisprudence* / Q000592:standards; D061214:Patient Safety; D018570:Risk Assessment; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence* / Q000379:methods / Q000592:standards; D014481:United States
chemical_list: D004337:Drug Carriers