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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Major Depressive Disorder: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Low Sexual Interest, Desire, and/or Arousal in Women: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
M10 BIOANALYTICAL METHOD VALIDATION  Food and Drug Administration (FDA) Proposed
M11 Clinical Electronic Structured Harmonised Protocol  Food and Drug Administration (FDA) Proposed
M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol  Food and Drug Administration (FDA) Proposed
M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines  Food and Drug Administration (FDA) Proposed
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed
Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials; Draft Guidance for Industry; Availability  Food and Drug Administration (FDA) Proposed
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations  Food and Drug Administration (FDA) Proposed
Meta-Analyses of Randomized Controlled Clinical Trials to Evaluate the Safety of Human Drugs or Biological Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.