US FDA Guidance for Industry Oct-Dec 2025

DateTitle of guidance and link to documentType and level
of guidance		About the guidance
23 Oct 2025Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome AssessmentsFinal, Level 1This guidance (Guidance 3) is the third in a series of four methodological patient-focused drug development (PFDD) guidance documents that describe how stakeholders (patients, caregivers,
researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients, caregivers, and clinicians to be used for medical product development and regulatory decision-making.
22 Oct 2025Expanded Access to Investigational Drugs for Treatment Use: Questions and AnswersLevel 1 Revised GuidanceThis guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access
to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009