CBER Plans to Issue COVID-19 Vaccine Guidance in 2020
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.
The center also intends to issue draft guidance this year on gene therapies for neurodegenerative diseases, on gene therapies that incorporate genome editing and on chimeric antigen receptor (CAR) T-cell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:
- Human gene therapy for hemophilia, retinal disorders and rare diseases;
- Chemistry, manufacturing and control (CMC) information for human gene therapy investigational new drug applications (INDs); and
- Long-term follow-up after administration of gene therapies; and interpreting the sameness of gene therapies under orphan drug regulations.
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: https://bit.ly/385GNpt.