The need for inclusion of pediatric information in the drug label has been recognized by many drug regulatory agencies in the world. To encourage pediatric labeling a final pediatric rule was issued by the FDA in 1994 , which allowed adult efficacy data to be applied to pediatric patients with the same disease or condition by supplementing and supporting the indication with dosing and safety data in pediatric populations. In 1996, the content and format for pediatric use supplement was issued . In 1997, the Food and Drug Modernization Act (FADMA) offered an incentive of six months extension of exclusivity to market the drug product if studies were performed in response to the FDA written request for pediatric studies. Readers can refer to FDA guidelines on qualifying for Pediatric Exclusivity under section 505(A) which was issued on June 30, 1998. In December 2001 FADMA expired, and in January 2002 the Best Pharmaceuticals for Children Act went into effect, which provided similar incentives as the FADMA. Other drug regulatory agencies in the world have also issued guidelines to conduct studies in pediatric populations and to include these populations in the product labeling. In August 1997, the Therapeutic Products Directorate, Canada issued the "Inclusion of Pediatric Subjects in Clinical Trials" guideline: in October 1997, the Australian Drug Evaluation Committee issued a report of a working party on the registration of drugs for use in children. In July 2000, ICH issued E 11 'Clinical Investigations of Medicinal Products in Pediatric Population.'
In order to decide if only PK study with safety data is sufficient to support pediatric indication or conduct of a PK and safety/efficacy trial will be needed, a decision tree has been published in the FDA's exposureresponse guidance and presented below as Fig. 1.
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