OCMO Guidance Documents
About OCMO Guidance Documents
The Office of the Chief Medical Officer (OCMO) provides executive leadership, coordination, and oversight of FDA cross-cutting clinical and public health emergency-related regulatory policy matters, including public health preparedness and response activities on behalf of the Commissioner. As part of this role, OCMO offices develop and issue guidance documents to support consistent and transparent regulatory practices in the areas they oversee. These documents are intended to assist industry and other interested parties in understanding regulatory expectations, complying with applicable laws, and developing new and innovative products that improve public health.
Guidance documents describe the FDA’s interpretation of, or policy on, a regulatory issue (21 CFR 10.115(b)). In general, FDA’s guidance documents do not establish legally enforceable responsibilities and thus are not binding on FDA or the public. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. Industry and researchers can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
Guidance Topics in OCMO
- Issues related to the development, review, and regulation of:
- Combination products
- Pediatric products
- Incentive programs for rare disease medical products
- Clinical trials and human subject protection
- Cross-cutting issues related to implementation of FDA’s medical countermeasure-related authorities
Guidance Agenda
Additional Resources
- About FDA Guidance Documents
- Search for FDA Guidance Documents
- FDA’s Good Guidance Practices Regulation
- How to Comment on Guidance Documents
Contact FDA
For further assistance, explore ways to contact the FDA.