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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Enforcement Policy -- OTC Sunscreen Drug Products Marketed Without an Approved Application  Food and Drug Administration (FDA) Final
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16).  Food and Drug Administration (FDA) Final
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity  Food and Drug Administration (FDA) Final
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry  Food and Drug Administration (FDA) Final
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry  Food and Drug Administration (FDA) Final
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers  Food and Drug Administration (FDA) Final
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle  Food and Drug Administration (FDA) Final
Evaluating the Risks of Drug Exposure in Human Pregnancies  Food and Drug Administration (FDA) Final
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