Pediatric drug development FDAMA

The FDAMA bill essentially codified and expanded several regulatory actions initiated by the FDA during the 1990s. Among the incentives offered by the bill, companies will be offered an additional six months of patent protection for performing pediatric studies (clinical trials) on already approved products. In fact, the FDA was mandated by FDAMA to develop a list of over 500 drugs for which additional information would produce benefits for pediatric patients. The FDA is supposed to provide a written request for pediatric studies to the manufacturers (Hart, 1999). 

The FDA Modernization Act (FDAMA) of 1997 contains within it financial incentives for the development and marketing of drugs that could be used for pediatric patients. Some of these incentives include an extension of 6 months on market exclusivity and waiving fees for supplemental applications needed for receiving the approval of drugs for pediatric use that are already approved for adult use. In addition, the FDA published a list of drugs approved in adults for which additional pediatric data may produce health benefits for pediatric... 

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