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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Using the Inactive Ingredient Database Guidance for Industry  Food and Drug Administration (FDA) Proposed
Waivers of the Single, Shared System REMS Requirement; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Draft Clinical/Medical  Food and Drug Administration (FDA) Proposed
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