FDA publishes CDER Guidance Agenda outlining planned drug guidance documents

12th March 2026

Summary:
The US Food and Drug Administration (FDA) has published the latest CDER Guidance Agenda from its Center for Drug Evaluation and Research (CDER), outlining guidance documents the agency is considering developing or revising during 2026. The agenda provides a forward look at potential regulatory guidance covering areas such as pharmaceutical manufacturing, clinical development, regulatory procedures and emerging technologies. Topics expected to be addressed include areas such as artificial intelligence and machine learning in pharmaceutical manufacturing, digital health technologies in clinical investigations and updated approaches to regulatory interactions and drug development processes. The agenda helps industry stakeholders understand areas where new or revised FDA guidance may be issued, although inclusion on the list does not guarantee that a guidance document will be published.

Link: https://www.fda.gov/drugs/guidances-drugs/cder-guidance-agenda

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