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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products  Food and Drug Administration (FDA) Proposed
Pulmonary Tuberculosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Risk Management Plans to Mitigate the Potential for Drug Shortages  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
REMS Logic Model: A Framework to Link Program Design With Assessment  Food and Drug Administration (FDA) Proposed
REMS Assessment: Planning and Reporting  Food and Drug Administration (FDA) Proposed
Public Availability of Labeling Changes in "Changes Being Effected" Supplements  Food and Drug Administration (FDA) Proposed
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Dry Eye: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3359 documents.

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