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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
Cancer Clinical Trial Eligibility Criteria: Brain Metastases  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections  Food and Drug Administration (FDA) Final
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies  Food and Drug Administration (FDA) Final
Carcinogenicity Study Protocol Submissions  Food and Drug Administration (FDA) Final
Cardiac Monitor Guidance (including Cardiotachometer and Rate Alarm) - Guidance for Industry  Food and Drug Administration (FDA) Final
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality  Food and Drug Administration (FDA) Final
Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 (Laser Notice 9)  Food and Drug Administration (FDA) Final
Changes or Modifications During the Conduct of a Clinical Investigation; Final Guidance for Industry and CDRH Staff  Food and Drug Administration (FDA) Final
Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.