FDA Provides Guidelines for Swine Respiratory Disease Studies

April 24, 2006 — 

The U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM) has published draft guidance document No. 178 entitled RECOMMENDED STUDY DESIGN AND EVALUATION OF EFFECTIVENESS STUDIES FOR SWINE RESPIRATORY DISEASE CLAIMS, DRAFT GUIDANCE providing recommendations to industry relating to study design and describes the criteria that the CVM intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims. CVM uses the term SRD to refer to the component of acute respiratory disease in swine associated with bacterial pathogens and does not consider SRD synonymous with "Enzootic Pneumonia", "Porcine Respiratory Disease Complex" (PRDC), or any other complex or syndrome.

Section 1 of the guidance suggests designs for studies intended to demonstrate the effectiveness of a new animal drug intended for the treatment or control of SRD. Section 2 of the guidance describes study design recommendations and criteria CVM intends to use to determine the effectiveness of a new animal drug intended for 1) treatment or control of SRD associated with Mycoplasma hyopneumoniae and other bacterial pathogens; or 2) reduction in severity of effects of respiratory disease associated with Mycoplasma hyopneumoniae.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word "should" in Agency guidances means that something is suggested or recommended, but not required.

This draft document is currently available for public comment. Comments and suggestions regarding this draft guidance should be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select "[insert Docket No. 2006D-0138] [Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims]" and follow the directions. All comments should be identified with Docket Number 2006D-0138.

Source:
FDA-CVM Guidance Document No. 178