As the race to develop an effective COVID-19 vaccine by year’s end gains momentum, the FDA said it plans to issue a guidance on developing and licensing them.
In a new guidance agenda for 2020, the FDA’s Center for Biologics Evaluation and Research (CBER) does not specify a release date or elaborate on the content of the guidance. But the agency has streamlined its guidance development process during the pandemic and can now produce a guidance in as little as two or three weeks, according to CBER’s Director Peter Marks (DID, June 19).
The center also intends to issue draft guidance this year on gene therapies for neurodegenerative diseases, on gene therapies that incorporate genome editing and on chimeric antigen receptor (CAR) T-cell therapies.
It also expects to issue final guidance on:
In addition, CBER said it aims to release guidance on interacting with the FDA on complex and innovative clinical trial designs for drugs and biological products.
Read CBER’s full guidance agenda for 2020 here: www.fdanews.com/06-25-20-CBERGuidanceAgenda.pdf. — James Miessler