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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens  Food and Drug Administration (FDA) Proposed
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers  Food and Drug Administration (FDA) Proposed
Pediatric Inflammatory Bowel Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Mpox: Development of Drugs and Biological Products; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
Migraine: Developing Drugs for Preventive Treatment  Food and Drug Administration (FDA) Proposed
Drug Interaction Information in Human Prescription Drug and Biological Product Labeling  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 3110 documents.

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