FDA Guidance Plans for 2026
Recommendation
17/18 June 2026
Copenhagen, Denmark
Supervision of the Pharmaceutical Quality System: Challenges and Opportunities
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The FDA's Center for Drug Evaluation and Research (CDER) has released its list of guidance documents that it is considering for development during the 2026 calendar year. The list includes both new Level 1 draft guidance as well as previously issued Level 1 guidance that are planned to be revised.
According to the FDA, the document reflects the agency's current planning priorities. However, the list is not binding, and CDER is not required to issue all guidance included. The agency also retains the flexibility to develop additional guidance documents on topics that are not listed.
The list also contains some planned pharmaceutical quality guidance documents, like for example:
- PET Drugs - Current Good Manufacturing Practice (CGMP); Revised Draft
- Responding to Form FDA 483 Observations at the Conclusion of a Drug CGMP inspection
- AI and ML Quality Considerations in Pharmaceutical Manufacturing
- Container Closure Systems for Drugs, Including Biological Products
- Postapproval Changes to Drug Substances; Revised Draft
- Site Master Files
- Stability Considerations and Recommendations
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