Regulating Nanomedicine – Can the FDA handle it, Medicine, Page 9
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| Page content: specific toxicity testing is needed to demonstrate their safety. However, stakeholders, government, industry, academia and the public at large have offered various proposals to regulate nanomedicine, including creating new laws and regulations, revising/modifying existing laws and regulations, interpreting existing laws and regulations to cover nanomedicine, designing new nonregulatory governance approaches such as voluntary industry standards and revising/modifying existing nonregulatory approaches [23]. NANOPRODUCTS AS COMBINATION PRODUCTS According to the US Code of Federal Regulation, 21 CFR Section 310.3 (g): "New drug substance means any substance that when used in the manufacture, processing, or packing of a drug, causes that drug to be a new drug, but does not include intermediates used in the synthesis of such substance." Therefore, nanoformulations (e.g., "nanopharmaceuticals ") of existing therapeutics are considered new formulations but not necessarily new molecular entities (NMEs). All nanopharmaceuticals currently on the market have been approved by the FDA according to preexisting laws and without any special testing (e.g., with respect to pharmacokinetic profiles). However, approval of new "nanoformulations" has challenged the FDA's regulatory framework. Products, including some that may contain nanomaterials or involve nanomedicine, submitted to the FDA for market approval are evaluated on a categorybased system in one of the nine Centers that focus on a specific area of regulation. For example, a drug, biologic, or device would be assigned for evaluation respectively to the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), or the Center for Devices and Radiological Health 9 | ||||||
