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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators  Food and Drug Administration (FDA) Proposed
Labeling for Combined Hormonal Contraceptives Guidance for Industry  Food and Drug Administration (FDA) Proposed
Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation  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
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed
M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes  Food and Drug Administration (FDA) Proposed
M9 Biopharmaceutics Classification System-Based Biowaivers  Food and Drug Administration (FDA) Proposed
Major Depressive Disorder: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50159 documents.

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