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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics 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
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank: Draft Guidance for FDA Staff, Responsible Parties, and Submitters of Certain Applications and Submissions to FDA  Food and Drug Administration (FDA) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft Compliance Guidance for the Durable Medical Equipment, Prosthetics, Orthotics and Supply Industry  Office of Inspector General (OIG) Proposed
Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Orange Book Questions and Answers Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Review and Update of Device Establishment Inspection Processes and Standards: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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