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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
CVM GFI #264 Standardized Medicated Feed Assay Limits  Food and Drug Administration (FDA) Proposed
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data  Food and Drug Administration (FDA) Proposed
Developing Products for Weight Management Revision 1  Food and Drug Administration (FDA) Proposed
Development and Submission of Near Infrared Analytical Procedures  Food and Drug Administration (FDA) Proposed
Development of a Shared System REMS Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Unapproved New Uses — Recommended Practices - Revised Guidance  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Level for Arsenic in Apple Juice   Food and Drug Administration (FDA) Proposed
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