Welcome To Website IAS

Hot news
Achievement

Independence Award

- First Rank - Second Rank - Third Rank

Labour Award

- First Rank - Second Rank -Third Rank

National Award

 - Study on food stuff for animal(2005)

 - Study on rice breeding for export and domestic consumption(2005)

VIFOTEC Award

- Hybrid Maize by Single Cross V2002 (2003)

- Tomato Grafting to Manage Ralstonia Disease(2005)

- Cassava variety KM140(2010)

Centres
Website links
Vietnamese calendar
Library
Visitors summary
 Curently online :  74
 Total visitors :  7641746

US FDA Releases Guidance for Heritable Intentional Genomic Alterations in Animals
Monday, 2024/06/03 | 08:22:07

ISAAA May 29, 2024

 

In May 2024, the U.S. Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) released Guidance for Industry (GFI) #187A “Heritable Intentional Genomic Alterations in Animals: Risk Based Approach” and draft GFI #187B “Heritable Intentional Genomic Alterations in Animals: The Approval Process” to clarify requirements and recommendations for developers of intentional genomic alterations (IGAs) in animals.

 

FDA defined IGAs in animals as “changes to an animal's genomic DNA produced using modern molecular technologies, which may include random or targeted DNA sequence changes including nucleotide insertions, substitutions, or deletions.” IGAs in animals have been used in various applications for improving human and animal health.

 

GFI #187A describes a risk-based regulatory approach to oversee IGAs in animals. The approach categorizes products into three levels: Category 1 products, which do not require consultation before marketing; Category 2 products, which may not need an approval application if risks are understood and mitigated; and Category 3 products, which require FDA review and approval based on data requirements proportionate to the associated risk.

 

The draft of GFI #187B provides technical guidance for obtaining FDA approval for IGAs in animals. It applies to IGAs categorized as Category 2 or 3 in GFI #187A. The FDA CVM intends to finalize GFI #187B in the future after consultations with stakeholders.

 

For more information, read the final guidance document of GFI #187A and the draft guidance document of GFI #187B on the FDA website.

 

Back      Print      View: 54

[ Other News ]___________________________________________________
  • Brazil offers an extra US $ 17 million to FAO projects as new government takes helm
  • 2014 in review – Another busy year
  • Growing concern for South Sudan`s herders as conflict displaces millions of cattle
  • Biotech and Traditional Farming are Compatible Approaches to Sustainable Agri, Study
  • Report: Weed Control Changes and Herbicide Tolerant Crops in the USA 1996-2012
  • New Study Provides Better Understanding of the Genetic Basis for Drought Tolerant Soybeans
  • Wheat Gene Increases Blight Resistance of American Chestnut Trees
  • China Approves Imports of Biotech Crops
  • IndoBIC Holds Media Visit to Seed Industries in East Java
  • FAO food price index drops in December
  • Origin Receives Biosafety Certificate Renewal for its GM Phytase Corn in China
  • Biotech Rice Expressing CP4-EPSPS Shows Glyphosate Tolerance
  • UK Govt Adviser Calls for Use of Agri Technologies that ``Produce More with Less``
  • Genetic diversity a hidden tool in coping with climate change
  • Cutting down on Amazon deforestation: Watch, think, and act
  • USDA Deregulates Dicamba-Tolerant Cotton and Soybean
  • NAS Holds Workshop on Communicating about GMOs
  • Cell Wall Traits for a FHB Resistant Durum Wheat
  • Ag Biotech Vietnam Conducts Biotech Quiz Contest at Northwestern University
  • Viet Nam Launches National Zero Hunger Challenge

 

Designed & Powered by WEBSO CO.,LTD