Antimicrobial Resistance Information from FDA

What’s new

• April 2, 2019: FDA announced a public meeting: Limited Population Pathway for Antibacterial and Antifungal DrugsExternal Link Disclaimer, which will be held July 12, 2019 in Silver Spring, MD and webcast. The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, Limited Population Pathway for Antibacterial and Antifungal Drugs that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance. Register by July 1, 2019. Submit comments by August 12, 2019.
• April 1, 2019: FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals – FDA announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. The agency also posted a list of the affected products. FDA’s Center for Veterinary Medicine (CVM) will accept research applications for the fiscal year 2019 program from April 1 to June 3, 2019.
• March 5, 2019: On April 8, 2019, FDA will hold a public workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Infection External Link Disclaimer(Silver Spring, MD and webcast) to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease. Register by April 4, 2019.
• February 27, 2019: On March 8, 2019, FDA experts will present at the workshop USFDA–CDSCO-DIA Workshop on Global Anti-Infective Drug Development: Challenges and OpportunitiesExternal Link Disclaimer (Mumbai, India), hosted by DIA.
• January 23, 2019: FDA permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women. Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.