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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not Been Reconditioned  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements  Food and Drug Administration (FDA) Proposed
Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers  Food and Drug Administration (FDA) Proposed
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices  Food and Drug Administration (FDA) Proposed
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry  Food and Drug Administration (FDA) Proposed
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment  Food and Drug Administration (FDA) Proposed
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry  Food and Drug Administration (FDA) Proposed
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