FDA Medical Countermeasures Initiative Update
FDA Takes Action against Zika VirusFDA is engaged with our partners across the U.S. Government, the private sector, and the international community—including the World Health Organization and ANVISA (the Brazilian Health Regulatory Agency)—to help minimize the impact of the Zika virus outbreak.
Read more about FDA's response from FDA Commissioner Dr. Robert Califf and Acting Chief Scientist Dr. Luciana Borio
Image: A female Aedes aegypti mosquito obtains a blood meal from a human host. Photo: James Gathany/CDC
HHS Summit to Accelerate Zika Diagnostics Development
July 15, 2016, Washington, DC and webcast
This summit will cover:
- Accelerating development of Zika diagnostics for Emergency Use Authorization (EUA) or clearance
- Facilitating developer access to clinical samples
- Identifying solutions to improve Zika diagnostic assay sensitivity and specificity
- Allowing assay developers and reagent creators the opportunity to form collaborations for better Zika diagnostics
In-person registration is full, but web conference participation is still available. Registration is required.
- Register to view the summit webcast
- Zika Virus Diagnostic Development
- Infographic on Zika diagnostic test development (PDF, 120 KB)
FDA Grand Rounds: FDA Research into 3D Printing of its Regulated Products
July 14, 2016, 12:00 - 1:00 p.m. ET
FDA internal and collaborative research underway seeks to facilitate the innovative development and assessment of innovative products in the additive manufacturing space. This presentation will provide a snapshot of ongoing research efforts internally and in collaboration with FDA’s academic partners.
Topics will include phantoms for device testing, patient-matched devices instrumentation, cleanability assessment, material optimization, and drug printing optimization.
- More about this presentation
- View the webcast live (link will not be active until shortly before event begins)
- New! July 14, 2016: Webinar - An Update on the FDA's Medical Device Clinical Trials Program- 2:00 - 3:30 p.m. ET - Registration is not necessary; however we expect high interest in the event and recommend you connect to the webinar at least 15 minutes prior to the start time.
- July 18-19, 2016: Medical Management of Radiation Casualties: Where Research and Usage Meet (Rockville, MD), hosted by the Radiation Injury Treatment Network and the National Institute of Allergy and Infectious Diseases (NIAID)
- July 18-19, 2016: Public Workshop - Facilitating Antibacterial Drug Development for Patients With Unmet Need and Developing Antibacterial Drugs That Target a Single Species Media(Silver Spring, MD)
- New! July 25, 2016: Webinar - Final Rule: Use of Symbols in Labeling, 1:00 - 2:30 ET - registration is not necessary - view the final rule (PDF, 581 KB), issued June 15, 2016
- New! August 1, 2016: Workshop - Integration of FDA and NIOSH Evaluation Processes of Respiratory Protective Devices for Health Care Workers (Washington, DC), hosted by the National Academies, Health and Medicine Division
- New! August 8, 2016: Webinar for FDA Final Guidance: Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices, 1:00 - 2:30 p.m. ET, registration is not necessary - view the guidance (PDF, 696 KB)
View more events on the frequently updated MCMi News and Events page
Guidance and information for industry:
- Final Guidance - Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices (PDF, 696 KB) - On August 8, 2016, FDA will host a webinar on this guidance, which provides a framework to consider extrapolating existing data to evaluate a device’s performance in pediatric patients in pre-market approval applications (PMAs), humanitarian device exemptions (HDEs) and de novo requests. It also facilitates continued efforts to address unmet medical device needs for pediatric patients. (June 21, 2016)
- Guidance - Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (PDF, 174 KB) (Federal Register notice) (July 1, 2016)
- Draft Guidance - Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (PDF, 499 KB) (Federal Register notice) - Also see: FDA advances Precision Medicine Initiative by issuing draft guidances on next generation sequencing-based tests and Precision Medicine (July 6, 2016)
In case you missed it:
- FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens - FDA cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. (June 29, 2016)
- In response to CDC's request to amend the CDC Zika MAC-ELISA EUA, FDA reissued the February 26, 2016, EUA in its entirety with the CDC-requested amendments (PDF, 494 KB) incorporated. More (June 26, 2016)
- More from FDA Voice: CBER Laboratories in the Life-Sciences Biodefense Complex (June 21, 2016) and FDA: A Great Place for Science...and for Scientists on the New Frontier of Regulatory Science (June 23, 2016)
- In Zika news from our partners, HHS moves to boost Zika vaccine capacity in Brazil (June 24, 2016); HHS calls on center for innovation to accelerate Zika vaccine development (June 27, 2016); NIH launches large study of pregnant women in areas affected by Zika virus [also seeQ&A on the Zika in Infants and Pregnancy (ZIP) Study] (June 21, 2016); and NIH funds Zika virus study involving U.S. Olympic team (July 5, 2016)