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Laws & Regulations 

Gene Therapy in the UnitedStates

 

•Did you know that the oversight of gene therapy and the gene therapy trials in the United States is controlled by the Department of Health and Human Services (DHHS)? 

 

•There are two branches of the DHHS

 

•Office for Human Research Protections (OHRP)-provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS).

 

•U.S. Food and Drug Administration (FDA)- is the primary government agency charged with protecting the health of U.S. citizens by ensuring that drugs, medical devices and biological products are safe and effective before they are used by doctors, nurses, other health care professionals, hospitals and consumers.

  • Center for Biologics Evaluation and Research (CBER)-

    • ​ they control the regulation of gene therapy trials.

  • The first thing that a manafacturer of a gene therapy product must do is test his or her product extensively through the FDA. It must be tested for

    • ​Safety

    • Potency

    • Purity

This page was created and designed by Jake Towery

Without scrolling to the top of the page name the organization who oversees gene therapy in the United States?

Trivia Question!

THE VIDEO BELOW explains more about 23 and me, and the future of genetically modifing babies!

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