July workshop on bacteriophage therapy | New MCM monitoring & assessment resource | FDA Commissioner's Fellowhip applications open

June 15, 2017  |  FDA Medical Countermeasures Initiative Update

Bacteriophage Therapy

Scientific and Regulatory Issues Public Workshop

July 10-11, 2017, Rockville, MD

Since their discovery approximately 100 years ago, bacteriophages have been investigated as a way to treat bacterial infections. In much of the world, the discovery, development, and implementation of antibiotic therapies led to a loss of interest in bacteriophages as a means to fight infections. However, in recent years, interest in this form of treatment has resurged, fueled by the increasing prevalence of antibiotic-resistant bacteria. 

The aims of the workshop are to discuss the scientific and regulatory considerations for bacteriophage therapies and to provide a forum for the exchange of information and perspectives, with the ultimate goal of facilitating development and rigorous clinical assessment of bacteriophage therapy products.

Related Information

• Register by June 29, 2017
• More about this workshop, hosted by FDA CBER and NIH/NIAID
• Bacteriophage therapy, brief history and overview (Sulakvelidze et al., 2001)

Image: Transmission electron microscope image of T4Phage, a bacteriophage that infects Escherichia coli bacteria. (Credit: Louisa Howard, Dartmouth)

Medical countermeasure monitoring and assessment In collaboration with the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), FDA is a key partner in developing a national capability to monitor and assess medical countermeasures (MCMs) after they are dispensed or administered in response to a chemical, biological, radiological, or nuclear threat or an emerging infectious disease. Visit our new MCM monitoring and assessment page to learn more.

Commissioner's Fellowship Program FDA invites outstanding healthcare professionals, scientists, and engineers to apply to our two-year Commissioner's Fellowship Program, where they will receive regulatory science training and the chance to conduct cutting-edge research on targeted scientific, policy, or regulatory issues under the mentorship of an FDA senior scientist. Apply by July 7, 2017, 5:00 p.m. ET Letters of recommendation are due July 20, 2017, 5:00 p.m. ET Proposed projects for the Class of 2017

More events

• NEW! June 15, 2017: CDER SBIA Webinar - Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive - 12:00 - 3:00 p.m. ET
• June 18-22, 2017: Drug Information Association (DIA) 2017  (Chicago, IL) - FDA Acting Assistant Commissioner for Counterterrorism Policy RADM Carmen T. Maher,  MA, BSN, RN, RAC will present on international collaboration in times of public health crisis (fee)
• NEW! June 19, 2017: CDER SBIA Webinar - The Ins and Outs of Presenting Clinical Pharmacology Information in Prescription Drug Labeling - 1:00 - 2:30 p.m. ET
• June 20-21, 2017: Combating Antimicrobial Resistance: A One Health Approach to a Global Threat—A Workshop  (Washington, DC and webcast), hosted by the National Academies of Sciences, Engineering and Medicine, Health and Medicine Division
• June 21-22, 2017: The Need to Accelerate Therapeutic Development — Must Randomized Controlled Trials Give Way? (New York, NY) Hosted by the NYU School of Medicine and the New York Academy of Sciences - FDA speakers include Dr. Janet Woodcock and Dr. Luciana Borio (event is sold out; free webcast will be available)
• NEW! June 26, 2017: Science Board to the FDA Advisory Committee meeting - the Science Board will hear an update on FDA's biotechnology activities related to plant-derived food and animals and will hear a report from the National Antimicrobial Resistance Monitoring System (NARMS) Review Subcommittee
• June 26-29, 2017: Third annual Biodefense World Summit (Alexandria, VA), hosted by the Knowledge Foundation - includes a keynote presentation: Rapid Surveillance of the Ebola Genome Sequence with Microarray Technology by Robert Duncan, PhD, FDA/CBER (agenda) (fee)
• NEW! July 6, 2017: Committee on Strategies for Identifying and Addressing Biodefense Vulnerabilities Posed by Synthetic Biology  (Washington, DC), hosted by the National Academies of Sciences, Engineering, and Medicine (in-person only)
• July 10, 2017: Public workshop - Sentinel Training at FDA (Silver Spring, MD and webcast) - Early registration  is recommended. Also see FDA's Sentinel Initiative
• NEW! July 17, 2017: Public workshop - Developing Rabies Monoclonal Antibody Products as a Component of Rabies Post-Exposure Prophylaxis (Silver Spring, MD and webcast) - Register by July 12, 2017.

Information for industry

• Final rule - technical amendment: FDA is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the FD&C Act as amended. (June 7, 2017)
• The process for qualification of drug development tools (DDTs) is changing under new FD&C Act Section 507. Also see information about these updates to the DDT submission processes (June 8, 2017)
• FDA is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to serve on DGMPAC. Submit nomination materials by July 14, 2017.

In case you missed it FDA leads effort to create a supply chain security toolkit for medical products - Protecting the integrity of the medical product supply chain is complex and requires a global approach. FDA led a collaboration within Asia Pacific Economic Cooperation (APEC) economies to create a Supply Chain Security Toolkit for Medical Products (PDF, 6.5 MB) to maximize available global resources and to deliver quality training and best practices for securing the global supply chain for medical products. (May 30, 2017) Zika updates from CDC MMWR: - Measures Taken to Prevent Zika Virus Infection During Pregnancy — Puerto Rico, 2016 (June 9, 2017) and Pregnancy Outcomes After Maternal Zika Virus Infection During Pregnancy — U.S. Territories, January 1, 2016–April 25, 2017 (June 8, 2017)  NIH research updates on Lassa virus structure(June 2, 2017) and antibodies from an Ebola survivor (June 6, 2017)