FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PATIENT-FOCUSED DRUG DEVELOPMENT: SELECTING, DEVELOPING, OR MODIFYING FIT-FOR-PURPOSE CLINICAL OUTCOME ASSESSMENTS; GUIDANCE FOR INDUSTRY, FOOD AND DRUG ADMINISTRATION STAFF, AND OTHER STAKEHOLDERS; AVAILABILITY

WASHINGTON, Nov. 18 -- Food and Drug Administration has issued a notice called: Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability.

The notice was published in the Federal Register on Nov. 18 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled "Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments." This guidance (Guid...