Category Guidance for industry

Title of guidance Type and level of guidance About the guidance Source Providing Over-the-Counter Monograph Submissions in Electronic Format Draft This guidance provides information on providing electronic submissions to FDA under section 505G of the FD&C Act) (21 U.S.C. 355h)…

On mobile, the table below is best viewed by scrolling sideways. Title of guidance Type and level of guidance About the guidance Source Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments Draft guidance This guidance (Guidance 3)…

Title of guidance Type and level of guidance About the guidance Source Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry Draft guidance This guidance: • is intended to assist applicants and holders of an abbreviated new…