jueves, 18 de agosto de 2016

Update on GE mosquitoes | New events & workshops

FDA Medical Countermeasures Initiative Update

FDA Releases Final Environmental Assessment for Genetically Engineered Mosquito

A female Aedes aegypti mosquito in the process of acquiring a blood meal from her human host. (Credit: CDC/James Gathany)

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

Image: A female Aedes aegypti mosquito in the process of acquiring a blood meal from her human host. (Credit: CDC/James Gathany)

News updates

  • 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! 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:
  • 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)
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