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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry  Food and Drug Administration (FDA) Final
Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry  Food and Drug Administration (FDA) Final
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry  Food and Drug Administration (FDA) Final
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment : Guidance for Industry  Food and Drug Administration (FDA) Final
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry  Food and Drug Administration (FDA) Final
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.