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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
Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
An Acceptable Circular of Information for the Use of Human Blood and Blood Components: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions | Amendments to Abbreviated New Drug Applications Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDA Submissions — Refuse to Receive for Lack of Justification of Impurity Limits: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs: Impurities in Drug Products: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs: Impurities in Drug Substances: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.