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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  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
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Benefit-Risk Considerations for Product Quality Assessments  Food and Drug Administration (FDA) Proposed
ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Alcoholism: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Procedures Manual Chapter 9 Subchapter on Recommending Customs' Seizure and Destruction of Imported Human and Animal Food That Has Not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
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
Assessment of Ovarian Toxicity in Premenopausal Adults During Drug Development for Oncologic Products  Food and Drug Administration (FDA) Proposed
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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