Antimicrobial Resistance Information

Antimicrobial Resistance Diagnostics Challenge

A federal prize competition (sponsored by NIH and HHS ASPR) is calling for innovative ideas for rapid, point-of-care laboratory diagnostic tests to combat the development and spread of drug-resistant bacteria, a rising public health threat.

The Antimicrobial Resistance Diagnostic Challenge will award $20 million in prizes over all phases of the competition for new, innovative and novel laboratory diagnostic tests. The diagnostic tests being sought are those that identify and characterize antibiotic resistant bacteria and those that distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics, a major cause of drug resistance. More

International Regulatory Cooperation

On September 1-2, 2016, FDA participated in a meeting with the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA, Japan) to discuss regulatory approaches for the evaluation of antibacterial agents.

The EMA, PMDA, and FDA consider that a robust response to the problem of antimicrobial resistance must be multi-faceted and that the regulatory approach for the evaluation of antibacterial agents is only one element of the total response that is required to encourage and accelerate new antibacterial drug development to meet patient needs. View the meeting summary (PDF, 34 KB)

Related Information

FDA Consumer Update - Cutting-Edge Technology Sheds Light on Antibiotic Resistance
FDA seeks public input on next steps to help ensure judicious use of antimicrobials in agriculture - comment by December 13, 2016 (Federal Register notice)
Antimicrobial resistance information for health professionals and consumers

Image: Antibiotic resistance happens when bacteria change or mutate in a way that makes the drugs we prescribe less effective. Antibiotic resistance causes ~2,049,422 illnesses & 23,000 deaths annually in the U.S. The Challenge offers a pool of $20 million to spur innovation toward the creation of rapid, point-of-care diagnostics to identify bacterial infections. (Source: NIH)

Emergency Use Authorization (EUA) banner

Zika EUA Updates

On September 23, 2016, FDA issued an EUA for emergency use of Vela Diagnostics USA, Inc.’sSentosa® SA ZIKV RT-PCR Test for the qualitative detection of RNA from Zika virus in human serum, EDTA plasma, and urine. Test results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in these specimens during the acute phase of infection and, according to the updated CDC Guidance for U.S. Laboratories Testing for Zika Virus Infection, up to 14 days in serum and urine (possibly longer in urine), following onset of symptoms, if present. Additional technical information, including Instructions for Use and fact sheets

On September 21, 2016, in response to CDC's request to amend the Trioplex Real-time RT-PCR Assay issued on March 17, 2016, FDA granted the CDC-requested amendments, including claims for detecting Zika virus, Dengue virus, and chikungunya virus RNAs in whole blood (EDTA) specimens.Additional technical information, including updated Instructions for Use and fact sheets

Guidance and information for industry

Draft guidance - FDA's Application of Statutory Factors in Determining When a REMS Is Necessary (PDF, 129 KB) - comment by November 21, 2016 (Federal Register notice) (September 21, 2016)
Draft guidance - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (PDF, 435 KB) - comment by November 21, 2016. (Federal Register notice) (September 21, 2016)
FDA is announcing the establishment of a docket to receive suggestions, recommendations, and comments on a list of biomarkers that were used as outcomes to develop FDA-approved new molecular entities and New Biological Therapeutics from October 2007 to December 2015. Comments will help FDA determine the utility of the list and may assist FDA in developing databases on biomarkers for drug development in the future. Comment by November 18, 2016.(September 19, 2016)
FDA is announcing a regional public meeting (Ottowa, Canada, and webcast) entitled “Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The purpose of this public meeting is to solicit public input prior to the next ICH Assembly meeting and the Expert Working Group meetings in Osaka, Japan. Submit comments by October 19, 2016, for the public meeting to be held October 24, 2016. (September 16, 2016)

More MCM-related guidance and information by date

Events

September 27-28, 2016: FDA Small Business Regulatory Education for Industry (REdI) Conference (Silver Spring, MD and webcast)
New! September 27, 2016: National Preparedness Month Twitter chat, hosted by@CDCEmergency, 1:00 - 2:00 p.m. ET - follow #CDCPrep2016
New! September 29, 2016: Public Workshop - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs) (Silver Spring, MD) - also see information about the draft guidance above
New! September 29-30, 2016: Adopting the International System of Units for Radiation Measurements in the United States: A Workshop (Washington, DC), hosted by CDC and NAS
New! October 13, 2016: Vaccines and Related Biological Products Advisory Committee (Silver Spring, MD and teleconference) - the committee will meet in open session to discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season
New! October 14, 2016: Public Meeting: Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act (Silver Spring, MD and webcast) - register by October 6, 2016
New! November 17-18, 2016: FDA will hold a public advisory committee meeting of the Blood Products Advisory Committee in Silver Spring, MD. On November 18, 2016, the Committee will meet in open session to hear an informational session on Zika virus and blood safety in the United States. (Federal Register notice)