FDA CDER Outlines Planned Drug Guidance for 2026

The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has published a list of guidance documents it plans to develop or revise during the 2026 calendar year. The list includes both new Level 1 draft guidance and previously issued Level 1 guidance that will be updated.

According to the agency, the document reflects its current planning priorities, but it is not binding. CDER noted that it may not issue all the guidance listed and retains the flexibility to introduce additional guidance on emerging topics not currently included.

Among the pharmaceutical quality topics expected to receive guidance are current good manufacturing practice (CGMP) requirements for PET drugs, responses to Form FDA 483 observations after CGMP inspections, and quality considerations for artificial intelligence and machine learning in pharmaceutical manufacturing.

Other areas highlighted include container closure systems for drugs and biologics, post-approval changes to drug substances, site master files, and stability considerations and recommendations for pharmaceutical products.

09-03-2026