FDA Medical Countermeasures Initiative Update
FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito
August 5, 2016 - FDA has completed the environmental review for a proposed field trial to determine whether the release of Oxitec Ltd.’s genetically engineered (GE) mosquitoes (OX513A) will suppress the local Aedes aegypti mosquito population in the release area at Key Haven, Florida.
After considering thousands of public comments, FDA has published a final environmental assessment (EA) (PDF, 3 MB) and finding of no significant impact (FONSI) (PDF, 198 KB) that agrees with the EA’s conclusion that the proposed field trial will not have significant impacts on the environment.
Related information
- Genetically Engineered Mosquitoes, on our Zika virus response page
- Genetically Engineered Animals overview from FDA
- Mosquito control, from CDC
- Zika virus response updates from FDA
News updates
Events:
- New! August 16, 2016: Microbiology Devices Panel of the Medical Devices Advisory Committee (Silver Spring, MD) - the committee will discuss and make recommendations regarding the appropriateness of clearing or approving of over-the-counter diagnostic tests for the detection of pathogens causing infectious diseases, focusing on respiratory and sexually transmitted infections
- New! August 16-17, 2016: Medical Countermeasures Dispensing Summit - National Capital Region (Washington, DC and webcast) - Federal, regional, state, and territorial stakeholders will come together to identify, discuss, and explore best practices in MCM planning and operations, hosted by the HHS Assistant Secretary for Preparedness and Response (other dates/locations available)
- New! September 12-13, 2016: Public Hearing - Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products(Bethesda, MD and webcast)
- New! September 12-13, 2016: Public Workshop - Pediatric Clinical Investigator Training(Bethesda, MD and webcast), hosted by the FDA Office of Pediatric Therapeutics and the Eunice Kennedy Shriver National Institute of Child Health and Human Development - The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling.Register by September 6, 2016. (Federal Register notice)
- New! September 13-14, 2016: Public Workshop - Sequencing Quality Control II - The purpose of the public workshop is to define the scope of project and study designs, and solicit participation of DNA sequencing community and stakeholders for data generation, management, analysis, and interpretation. (Bethesda, MD) (Federal Register notice)
- New! September 23, 2016: Pediatric Master Protocols public workshop (Silver Spring, MD and webcast), hosted by FDA and the University of Maryland Center of Excellence in Regulatory Science and Innovation - The objective of the workshop is to discuss regulatory and scientific concerns related to pediatric master protocols and clinical trial design considerations for these protocols. Advance registration is required. (There is a registration fee to attend this public workshop in-person; there is no fee to view the webcast.) (Federal Register notice)
View more events on the frequently updated MCMi News and Events page
Guidance and information for industry:
- FDA issued draft updated recommendations (PDF, 1.6 MB) to help manufacturers determine when they are required to notify the FDA about modifications made to certain medical devices already on the market (Federal Register notice), including a separate guidance(PDF, 784 KB) applicable to software devices (Federal Register notice). Submit comments by November 7, 2016. Read the news release (August 5, 2016)
- The HHS Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, and FDA are announcing the availability of a draft guidance: Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (PDF, 163 KB). This draft guidance is intended to assist IRB administrators, IRB chairpersons, and other institutional officials responsible for preparing and maintaining written procedures for the IRB. The draft guidance provides an IRB Written Procedures Checklist that incorporates the FDA and HHS regulatory requirements for IRB written procedures and additional topics that FDA and OHRP recommend including in IRB written procedures. Submit comments byOctober 3, 2016. (Federal Register notice) (August 2, 2016)
In case you missed it:
- FDA Voice - FDA Working to Keep the U.S. Blood Supply Safe from Emerging Threats, by Peter Marks, MD, PhD and Luciana Borio, MD - en Español: La FDA actúa para mantener el suministro de sangre de los Estados Unidos a salvo de amenazas inminentes (August 5, 2016)
- FDA issued an EUA to authorize the emergency use of Luminex Corporation’s xMAP® MultiFLEX™ Zika RNA Assay for the qualitative detection of RNA from Zika virus in human serum, plasma, and urine. Also see Zika Emergency Use Authorization information - More about EUAs (August 4, 2016)
- HHS declares a public health emergency in Puerto Rico in response to Zika outbreak - Coordinating with the government of Puerto Rico to help combat the virus, which puts thousands of pregnant women at risk (August 12, 2016)
- NIH begins testing investigational Zika vaccine in humans - also see Q&A: Phase 1 Clinical Trial of the NIAID Zika Virus Investigational DNA Vaccine (August 3, 2016)
- Consumer Update: FDA researchers advance science for vaccines to prevent mumps and whooping cough (August 2, 2016)
- From CDC - Safe travels for Zika and other dangerous samples - CDC manages the permit process for researchers to bring samples of Zika virus safely from other countries into the U.S. for studies (August 2, 2016)
- How do clinical holds impact drug development programs? A conversation with Larissa Lapteva, MD, FDA Center for Drug Evaluation and Research (August 4, 2016)
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