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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Q3C: Appendix 4  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 6  Food and Drug Administration (FDA) Proposed
Qualification of Biomarker — Galactomannan in studies of treatments of invasive  Food and Drug Administration (FDA) Proposed
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Qualified Infectious Disease Product Designation Questions and Answers  Food and Drug Administration (FDA) Proposed
Quality Considerations for Continuous Manufacturing  Food and Drug Administration (FDA) Proposed
Rare Diseases: Common Issues in Drug Development Guidance for Industry  Food and Drug Administration (FDA) Proposed
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act  Food and Drug Administration (FDA) Proposed
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry  Food and Drug Administration (FDA) Proposed
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