The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment and prevention of disease caused by respiratory syncytial virus (RSV) infection. Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products that support an indication for treatment and prevention of disease caused by RSV infection. This draft guidance is intended to serve as a focus for continued discussions among the Division of Antiviral Products (DAVP), pharmaceutical sponsors, the academic community, and the public.3 24 This guidance focuses primarily on the development of drugs with antiviral mechanism for RSV-related illness in infants and young children (e.g., bronchiolitis) but also briefly discusses development for other populations. The sections of this guidance that discuss nonclinical development are intended to provide guidance regarding drug development for both prophylaxis and treatment.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.