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 :  5
 Total visitors :  7684077

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For more information, read the final guidance document of GFI #187A and the draft guidance document of GFI #187B on the FDA website.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: 65

[ Other News ]___________________________________________________
  • Egypt Holds Workshop on New Biotech Applications
  • UN Agencies Urge Transformation of Food Systems
  • Taiwan strongly supports management of brown planthopper—a major threat to rice production
  • IRRI Director General enjoins ASEAN states to invest in science for global food security
  • Rabies: Educate, vaccinate and eliminate
  • “As a wife I will help, manage, and love”: The value of qualitative research in understanding land tenure and gender in Ghana
  • CIP Director General Wells Reflects on CIP’s 45th Anniversary
  • Setting the record straight on oil palm and peat in SE Asia
  • Why insect pests love monocultures, and how plant diversity could change that
  • Researchers Modify Yeast to Show How Plants Respond to Auxin
  • GM Maize MIR162 Harvested in Large Scale Field Trial in Vinh Phuc, Vietnam
  • Conference Tackles Legal Obligations and Compensation on Biosafety Regulations in Vietnam
  • Iloilo Stakeholders Informed about New Biosafety Regulations in PH
  • Global wheat and rice harvests poised to set new record
  • GM Maize Harvested in Vietnam Field Trial Sites
  • New label for mountain products puts premium on biological and cultural diversity
  • The Nobel Prize in Physiology or Medicine 2016
  • Shalabh Dixit: The link between rice genes and rice farmers
  • People need affordable food, but prices must provide decent livelihoods for small-scale family farmers
  • GM Seeds Market Growth to Increase through 2020 Due to Rise in Biofuels Use

 

Designed & Powered by WEBSO CO.,LTD