Fda.gov

Pharmaceutical companies should prepare to assess the impact of hepatic impairment early in drug development, particularly for drugs that require pharmacokinetic assessments.

Small business dispensers are encouraged to complete a mandatory assessment survey by September 22, 2026, and do not need to submit information to the FDA while utilizing these exemptions.

Stakeholders are advised to submit comments on the draft guidance by 11/18/2026, using docket number FDA-2026-D-8561 to ensure FDA considers their feedback before finalizing the document.