The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of gastroesophageal reflux disease (GERD) in the pediatric patient population, including guidance on clinical presentation by age and disease, study populations, endpoints, and pharmacometric issues affecting dosing.
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Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Gastroesophageal Reflux Disease: Developing...
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82 FR 49837
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“Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability,” thefederalregister.org (October 27, 2017), https://thefederalregister.org/documents/2017-23436/pediatric-gastroesophageal-reflux-disease-developing-drugs-for-treatment-draft-guidance-for-industry-availability.