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(3) Although guidance documents do not legally bind FDA, they represent the agency's current thinking. Therefore, FDA employees may depart from guidance documents only with appropriate justification …

Guidance documents represent the Agency'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.

May 21, 2025 · The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product …

Jan 23, 2025 · The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has released a new guidance agenda detailing the new and revised guidance documents …

Jan 12, 2026 · The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) released the 2026 guidance agenda on Friday, outlining topics the agency is considering for …

Jan 22, 2025 · The Draft Guidance explains FDA’s interpretation of the general requirements for drug product manufacturing in § 211.110 and addresses considerations specific to the use of advanced …

Jan 17, 2025 · FDA guidance documents discuss the production, labeling, manufacturing of regulated products and denote FDA's current thinking and policy interpretation.

Jan 12, 2026 · Explore the FDA's updated guidance on AI and wearables, easing regulations to promote faster market entry and broader use of digital health technologies.

Dec 2, 2025 · At the end of November, the FDA published a roadmap for planned guidance documents for the current fiscal year 2026.