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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postapproval Pregnancy Safety Studies Guidance for Industry   Food and Drug Administration (FDA) Proposed
Qualification of Biomarker — Galactomannan in studies of treatments of invasive  Food and Drug Administration (FDA) Proposed
S5(R3) Detection of Toxicity to Reproduction  Food and Drug Administration (FDA) Proposed
Survey Methodologies to Assess REMS Goals That Relate to Knowledge  Food and Drug Administration (FDA) Proposed
Bridging for Drug-Device and Biologic-Device Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Field Alert Report Submission: Questions and Answers Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
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