viernes, 27 de octubre de 2017

New Guidance on Developing Drugs for Treatment of Pediatric GERD & Public Workshop on Patient-Focused Drug Development: Collecting Comprehensive Input

Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment Guidance for Industry



New Guidance on Developing Drugs for Treatment of Pediatric GERD & Public Workshop on Patient-Focused Drug Development: Collecting Comprehensive Input






1. Pediatric Gastroesophageal Reflux Disease: Developing Drugs for Treatment; Draft Guidance for Industry
The purpose of this 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.
2. Public Workshop on Patient-Focused Drug Development: Guidance 1 – Collecting Comprehensive and Representative Input
FDA is announcing a public workshop to convene a discussion on topics related to approaches to collecting comprehensive and representative patient and caregiver input on burden of disease and current therapy. The purpose of this public workshop is to obtain feedback from stakeholders on considerations for: (1) Standardized nomenclature and terminologies for patient-focused drug development, (2) methods to collect meaningful patient input throughout the drug development process, and (3) methodological considerations for data collection, reporting, management, and analysis of patient input.
The public workshop will be held on December 18, 2017.

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