FDA Classification

Teratology. Society (1994). FDA classification system of drugs for teratogenic risk. Teratology 49, 446- 47. 

In its continuing effort to improve the safety and efficacy of drugs in the pediatric population, the U.S. Food and Drug Administration (FDA) has defined five subgroups of this population based on age. Each subgroup is not homogeneous but does contain similar characteristics that are considered milestones in growth in development. The FDA classifications are listed in Table 1. 

Category No data available (not a formal FDA classification included to provide complete dataset). 

Note All FDA classifications are based on information available at the following URL http //www.fda.g0v/cder/dmg/drugInteracti0ns/tableSubstrates.htm classInhibit FDA-preferred in vitro substrate, inhibitor, or inducer FDA-acceptable in vitro substrate, inhibitor, or inducer... 

According to the FDA classification, the potential therapeutic benefits of vinca alkaloids have to be outweighed with the potential teratogenic risks (FDA classification D). All women of childbearing potential should be advised to avoid becoming pregnant while receiving cytotoxic cancer chemotherapy (80). 

Birth Control Drugs Anabolic Steroids Over-the-Counter Drugs FDA Classification Analgesics... 

Original work reproduced from Hill et al. (2012) with kind permission from Informa Healthcare. FDA classification list according to Chen et al. (2011). 

As discussed above, the particular program(s) of regulatory review applicable to a medical product are predetermined according to its FDA classification. Thus, the FD C Act requires a sponsor to submit a device Pre-Market AppKcation (PMA) or Product Development Protocol (PDP) to market a device, or... 

In the FDA classification. Class I medical devices have the least amount of regulatory control, and present minimal potential harm to the user. Class I devices are typically simple in design and manufacture, and have a history of safe use. Examples include tongue depressors, arm slings, and handheld surgical instruments. Most Class I devices are exempt from premarket notification, and may be exempt from compliance with the GMP regulation. 

Can one imagine the utility of a dispersed-phase reinforcement for polymers that has a thickness of 1 nm, a platelike morphology with minimal dimensions of 150 to 200 nm, robust with a modulus of 180 GPa, nontoxic (FDA classification of GRAS generally regarded as safe for a majority of applications), a surface area in excess of 750 m /g, a charge suitable for altering its hydrophobic-hydrophilic balance at will, and a refractive index similar to polymer so that the nanoparticles will appear transparent in the polymer composite How difficult would it be to prepare such a particle ... 

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