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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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
Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rheumatoid Arthritis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines  Food and Drug Administration (FDA) Proposed
S5(R3) Detection of Toxicity to Reproduction  Food and Drug Administration (FDA) Proposed
Safety Assessment for IND Safety Reporting Guidance for Industry  Food and Drug Administration (FDA) Proposed
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