CBER Issues 2020 Guidance Agenda

CBER unveiled its guidance agenda for the 2020, including planned draft guidances on gene therapy for neurodegenerative diseases, CAR-T cell therapies and genome editing.

The center also plans to publish final guidance on interacting with the FDA on complex and innovative trial designs for drugs and biological products.

The agenda also calls for the release of a final guidance on chemistry and manufacturing control (CMC) changes to an approved biologic. The center issued a draft CMC guidance in December 2017.

CBER already issued seven guidances, including three for sponsors of gene therapy products for specific rare diseases.