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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
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
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors  Food and Drug Administration (FDA) Proposed
Sample formats for Form FDA 356h_2011  Food and Drug Administration (FDA) Proposed
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products  Food and Drug Administration (FDA) Proposed
SPL Standard for Content of Labeling Technical Qs & As  Food and Drug Administration (FDA) Proposed
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