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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
CPG Sec. 370.100 Cytotoxic Testing for Allergic Diseases  Food and Drug Administration (FDA) Final
CPG Sec. 400.500 Identical or Similar Product Names  Food and Drug Administration (FDA) Final
CPG Sec. 355.300 Ion Generating Devices  Food and Drug Administration (FDA) Final
CPG Sec. 231.100- *Platelets, Pooled* is obsolete and was withdrawn on 7/16/2018.  Food and Drug Administration (FDA) Final
CPG Sec. 231.120- Time Period for Separation of Platelets from Platelet-Rich Plasma When Preparing *Platelets* and Fresh Frozen Plasma* is obsolete and was withdrawn on 7/16/2018.  Food and Drug Administration (FDA) Final
CPG Sec. 345.300 Menstrual Sponges  Food and Drug Administration (FDA) Final
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies  Food and Drug Administration (FDA) Final
CPG Sec. 231.130- Storage of *Platelets* [ ] for up to five (5) Days is obsolete and was withdrawn on 7/16/2018.  Food and Drug Administration (FDA) Final
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies  Food and Drug Administration (FDA) Final
CPG Sec. 448.100 Reconditioning of New Drugs Which Do Not Have Approved NDAs/ANDAs  Food and Drug Administration (FDA) Final
This Guidance Portal contains 5495 documents.