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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
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
REMS Assessment: Planning and Reporting  Food and Drug Administration (FDA) Proposed
Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act  Food and Drug Administration (FDA) Proposed
Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Proposed
Respiratory Syncytial Virus Infection: Developing Antiviral Drugs for Prophylaxis and Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
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