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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
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers  Food and Drug Administration (FDA) Proposed
Attachement - Qualification Process for Drug Development Tools: Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients With Chronic Obstructive…  Food and Drug Administration (FDA) Proposed
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs  Food and Drug Administration (FDA) Proposed
Certification Process for Designated Medical Gases: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11354 documents.