Section 505APediatric Studies of Drugs

As a result of the FDA Modernization Act (1997) [ fdama], the FDCA was amended to address pediatric drug studies among other things. If it was determined (i) for 505(b)(l) applications before a new drug's approval (i.e., before 2002), or (ii) for an already approved drug that is identified on a list prepared by FDA, that information related to the use of the drug in the pediatric population may provide health benefits to this population, a written request could be sent to the drug manufacturer or sponsor to conduct a pediatric study(s). Pediatric studies may only need to include "pharmacokinetic studies," if appropriate, as compared to the more classical clinical safety and efficacy studies. This assumes that (i) the disease being treated or diagnosed is similar in nature between adult and pediatric patients, (ii) there would be a similar safety profile between adult and pediatric patients, and (iii) there are similar PK (and PD relationships if known) between the two populations. If a study(s) is carried out as requested and specified by FDA, the applicant could obtain six months of additional marketing exclusivity for an NDA. After January 1, 2002 all newly submitted NDAs must include pediatric information if appropriate. However, the 2002 Best Pharmaceuticals Act for Children extended the time to allow drug sponsors to apply for six months marketing exclusivity until October 2007 for both new NDAs or drugs on FDAs list for which pediatric information would be important to obtain.

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