Oncology Center of Excellence Guidance Documents
OCE Guidance Agenda
The Oncology Center of Excellence (OCE) is sharing potential topics for new and updated guidance documents. While we plan to develop guidance for these topics, this list is not binding, and we may adjust our priorities based on various factors, including new administration initiatives, emerging public health needs, or other circumstances. We may also develop guidance on topics not listed here.
To comment on these guidance topics, please visit Regulations.gov and reference Docket FDA-2024-N-5352.
Some FDA guidance documents on the chart below may be indicated as open for comment. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment before it begins work on the final version of the guidance, submit either electronic or written comments by the closing date. Comments are submitted electronically through Regulations.gov. For more information, see:
Guidance documents represent the FDA's current thinking on a particular subject. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. For information on a specific guidance document, please contact the originating office. Another method to obtain guidance documents is through the Division of Drug Information.