The US FDA’s Center for Drug Evaluation and Research (CDER) has published the list of guidance documents it aims to issue this year.
The list of planned guidance documents – available here – provides an insight into what the Food and Drug Administration (FDA) considers to be key issues for the pharmaceutical sector, with hot topics like drug biosimilarity and generics being the focus on considerable CDER attention.
The documents – some of which have been published already – are intended to guide the pharmaceutical industry’s activities in drug development in a way that ensures products approved and sold in the US are safe.
In January an FDA Good Guidance Practice (GGP) working group called on drugmakers to submit draft guidance proposals to accelerate the development of regulations that benefit all stakeholders. The agency has not said if the CDER list contains any such submissions.