The U.S. Food and Drug Administration has issued new draft guidance for companies developing antibacterial drugs to fight infections caused by drug-resistant organisms.

The number of antibacterial drugs in development has dwindled in recent years, creating a problem given the growing number of bacteria that have developed resistance to current treatments.

The new guidance outlines how nonclinical and clinical data can be used to design efficient pathogen-focused antibacterial drug development programs. It also details the agency’s willingness to streamline reviews for antibacterials that act via a new mechanism of action, neutralize drug resistance, or alter the structure of drug molecules in ways that help break through resistance.

Acute bacterial diseases such as hospital-acquired and community-acquired bacterial pneumonia have created a growing health crisis in which an increasing numbers of patients suffer with bacterial infections that are unresponsive to current therapies. The agency says that it wants to “foster new antibacterial drug development that will have the potential to keep pace with continued pressures leading to antibacterial resistance.”

The guidance, entitled “Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases,” was drafted in response to a provision of the Generating Antibiotic Incentives Now Act of 2011. The agency hopes it will spur the development of narrow-spectrum antibacterials active against a single genus and species of bacteria, but also facilitate development of drugs for more broad indications.

Guidance documents issued by the agency are intended to reflect its current thinking on the topic addressed, but also to solicit new input. In particular, the FDA says it is interested in hearing about approaches such as using information from other sites of infection; pooling data from various sites; additional clinical trial endpoints; an increased emphasis on the use of animal data to complement clinical data; or any other approaches that may be useful for generating reliable evidence of efficacy.

The guidance does not establish any new rules and is open for comments through September 30.