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GUIDANCE DOCUMENT

CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims October 2007

Final

CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims

Docket Number:
FDA-2006-D-0479
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides recommendations to industry relating to study design and describes the criteria that the Center for Veterinary Medicine (CVM) intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims.

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. CVM uses the term SRD to refer to the component of acute respiratory disease in swine associated with bacterial pathogens such as Actinobacillus pleuropneumoniae, Bordetella bronchiseptica, Haemophilus parasuis, Pasteurella multocida, or Streptococcus suis.

For the purposes of this guidance, SRD is not considered synonymous with “Enzootic Pneumonia,” “Porcine Respiratory Disease Complex” (PRDC), or any other complex or syndrome. Enzootic Pneumonia is a common term used to describe Mycoplasma hyopneumoniae co-infection with other bacterial respiratory pathogens (such as P. multocida). PRDC is mixed viral and bacterial infection of two or more respiratory pathogens, such as M. hyopneumoniae, A. pleuropneumoniae, S. suis, P. multocida, Pseudorabies virus, Porcine Reproductive and Respiratory Syndrome Virus (PRRSV), and/or Swine Influenza Virus (SIV).

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2006-D-0479.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002