CBER Guidance Agenda Lists Two Trial-Related Documents Still to Come in 2022
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued an updated agenda of guidances it intends to publish this year, indicating there are still two clinical research documents the center intends to address by the end of the year.
Under the category of tissues and advanced therapies, CBER plans to release a guidance on evaluating multiple versions of a cell or gene therapy in early-phase trials.
The vaccines category includes a proposed guidance on the FDA’s enforcement policy for investigational new drug requirements for transplanted fecal microbiota to treat Clostridioides difficile infections that don’t respond to standard therapies.
As with all yearly guidance agendas, the center is not bound by its list, nor is it required to publish all of the guidances on it.
Read the updated agenda here: https://bit.ly/3NjPbEw.