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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Assessment of Pressor Effects of Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
Certification Process of Designated Medical Gases  Food and Drug Administration (FDA) Proposed
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies  Food and Drug Administration (FDA) Proposed
CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials  Food and Drug Administration (FDA) Proposed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
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