Our Website Uses Cookies
We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.
For more information, please contact us or consult our Privacy Notice.
Your binder contains too many pages, the maximum is 40.
We are unable to add this page to your binder, please try again later.
This page has been added to your binder.
- Home
- News and Insights
- Insights
- FDAs Human Gene Therapy Draft Guidances Steps Toward a Modern Framework for the Regulation of Gene Therapy
FDA’s Human Gene Therapy Draft Guidances: Steps Toward a Modern Framework for the Regulation of Gene Therapy
July 27, 2018, Covington Alert
On July 11, 2018, the U.S. Food and Drug Administration (FDA or the Agency) made available a suite of six scientific draft guidance documents on human gene therapy (GT) products.
July 23, 2020, Covington Alert
FDA announced this week that it intends to extend its enforcement discretion policy regarding investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products through May 2021. In light of the COVID-19 emergency, manufacturers will have six additional months after the initial November 2020 deadline to prepare and ...
November 21, 2017, Covington Alert
In a July 7, 2017 post to the FDA Voice blog, FDA Commissioner Scott Gottlieb announced that FDA would be releasing a “comprehensive regulatory framework” for regenerative medicine products. On November 16, 2017, FDA issued four guidance documents outlining certain aspects of that framework. This alert summarizes each of the guidance documents and highlights ...
November 7, 2017, Covington Alert
On August 18, 2017, President Donald Trump signed into law the FDA Reauthorization Act of 2017 (FDARA). This law, containing nine titles, reauthorizes and amends the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilars.