With Big Wave of Gene Therapy Products Moving to Clinical Trials FDA Prepares with More Guidance

With Big Wave of Gene Therapy Products Moving to Clinical Trials FDA Prepares with More Guidance

To date, the U.S. Food and Drug Administration (FDA) has approved four gene therapy products, which insert new genetic material into a patient’s cells. The agency expects a boom in gene therapy product approvals in the coming decade as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA recently issued a press release announcing they believe this will provide patients and providers with increased therapeutic choices. Consequently, the agency announced the release of a number of important policies including: six final guidelines on gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations.

Overview: Guidance for Gene Therapy Manufacturers

The six final guidance issued today provide the agency’s recommendations for product developers on manufacturing issues and recommendations for those focusing on gene therapy products to address specific disease areas. The six guidance documents incorporate input from many stakeholders and take a significant step toward helping to shape the modern structure...

Note:  If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).

$5 / Month
Individuals at home that are reading our content for personal health care or other non-professional reasons.
Like a Starbucks a month
Personal - Single Payment
$50 for 1 Year
Individuals - reading for personal reasons who prefer to pay for one year in advance with no recurring billing.
18% discount to monthly
$12 / Month
Professionals from the healthcare industry who are subscribing on behalf of their company for work reasons.
Way better than coffee