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Regulatory Hurdles for Nanoparticle-Based Therapies : Nanoparticle-based therapies face regulatory hurdles such as lack of standardized guidelines, complexity of preclinical and clinical studies, difficulty in characterization, and intellectual property issues

Strategy 6: Citizens Petitions as Regulatory Delay Instruments The FDAs citizen petition process, codified in 21 CFR 10.30, allows any person including corporations and trade associations to petition the FDA to issue, amend, or revoke a regulation, or to take other action

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Int J Child Neuropsychiatry (2005) 2:17988