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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials  Food and Drug Administration (FDA) Proposed
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry  Food and Drug Administration (FDA) Proposed
Fabry Disease: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry   Food and Drug Administration (FDA) Proposed
Labeling for Combined Hormonal Contraceptives Guidance for Industry  Food and Drug Administration (FDA) Proposed
Nonclinical Safety Evaluation of the Immunotoxic Potential of Drugs and Biologics Guidance for Industry  Food and Drug Administration (FDA) Proposed
Population Pharmacokinetics  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 6  Food and Drug Administration (FDA) Proposed
S11 Nonclinical Safety Testing in Support of Development of Paediatric Medicines  Food and Drug Administration (FDA) Proposed
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