Back To: Home

CLICK HERE FOR WHAT'S NEW IN:
 




 

Gene therapy guidances
March 2020
SHARING OPTIONS:

The FDA issued six final guidances recently on gene therapy manufacturing and clinical development of products, as well as a draft guidance. The FDA notes in a press release that clinical review of gene therapy products will by its nature be more complicated than that of traditional drugs, given that issues “such as questions about the durability of response … often can't be fully answered in pre-market trials of reasonable size and duration … Effective tools for reliable post-market follow up, such as post-market clinical trials, are going to be key to advancing this field and helping to ensure that our approach fosters safe and innovative treatments.” The draft guidance, “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations,” details the FDA's current thoughts regarding sameness between gene therapy products in terms of securing orphan drug designation and exclusivity. The FDA is welcoming comments on this guidance.

Back



PAGE UTILITIES


CONTACT US
DDNEWS
478 Bay Street, Suite A213
Midland, Ontario, Canada L4R 1K9
Ph: 888-781-0328 |  Fax: 705-528-0270
 
© Copyright 2020 Old River Publications LLC. All righs reserved.  |  Web site managed and designed by OffWhite.