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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry  Food and Drug Administration (FDA) Final
Content and Format for Geriatric Labeling  Food and Drug Administration (FDA) Final
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products  Food and Drug Administration (FDA) Final
Content of Investigational Device Exemptions for Solutions for Hypothermic Flushing, Transport and Storage of Organs for Transplantation - Guidance for Industry and FDA Reviewers  Food and Drug Administration (FDA) Final
Contents of a Complete Submission for the Evaluation of Proprietary Names  Food and Drug Administration (FDA) Final
Convenience Kits Interim Regulatory Guidance  Food and Drug Administration (FDA) Final
Coronary and Peripheral Arterial Diagnostic Catheters - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Court Decisions, ANDA Approvals, and 180-Day Exclusivity Under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
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