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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
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Final
Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Final
Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry  Food and Drug Administration (FDA) Final
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry  Food and Drug Administration (FDA) Final
Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food Drug and Cosmetic Act  Food and Drug Administration (FDA) Final
Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Conducting Clinical Trials With Decentralized Elements  Food and Drug Administration (FDA) Final
Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies  Food and Drug Administration (FDA) Final
Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products  Food and Drug Administration (FDA) Final
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.