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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
FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry  Food and Drug Administration (FDA) Final
FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Field Alert Report Submission: Questions and Answers Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Food-Effect Bioavailability and Fed Bioequivalence Studies: Guidance for Industry  Food and Drug Administration (FDA) Final
Format and Content of the Microbiology Section of an Application*: Guidance for Industry  Food and Drug Administration (FDA) Final
Format and Content of the Nonclinical Pharmacology/Toxicology Section of an Application*: Guidance for Industry  Food and Drug Administration (FDA) Final
Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products - Small Entity Compliance Guide: Guidance for Industry  Food and Drug Administration (FDA) Final
Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus: Guidance for Industry  Food and Drug Administration (FDA) Final
Generic Drug User Fee Amendments of 2012: Questions and Answers Related to User Fee Assessments: Guidance for Industry  Food and Drug Administration (FDA) Final
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.