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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
Providing Over-the-Counter Monograph Submissions in Electronic Format  Food and Drug Administration (FDA) Final
Providing Postmarket Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report)  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic and Non-Electronic Format—Promotional Labeling and Advertising Materials for Human Prescription Drugs  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format -- Standardized Study Data  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Content of Labeling  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format — Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format: IND Safety Reports Guidance for Industry  Food and Drug Administration (FDA) Final
Providing Regulatory Submissions in Electronic Format; General Considerations  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.