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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Survey Methodologies to Assess REMS Goals That Relate to Knowledge  Food and Drug Administration (FDA) Proposed
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations  Food and Drug Administration (FDA) Proposed
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry  Food and Drug Administration (FDA) Proposed
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry  Food and Drug Administration (FDA) Proposed
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry  Food and Drug Administration (FDA) Proposed
Ulcerative Colitis: Clinical Trial Endpoints Guidance for Industry  Food and Drug Administration (FDA) Proposed
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry  Food and Drug Administration (FDA) Proposed
Upper Facial Lines: Developing Botulinum Toxin Drug Products  Food and Drug Administration (FDA) Proposed
Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
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