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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Insanitary Conditions at Compounding Facilities Guidance for Industry  Food and Drug Administration (FDA) Proposed
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
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
This Guidance Portal contains 50173 documents.

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