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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Patients with Organ Dysfunction or Prior or Concurrent Malignancies  Food and Drug Administration (FDA) Proposed
Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions to Drug and Biologic Applications  Food and Drug Administration (FDA) Proposed
CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Action Level for Arsenic in Apple Juice   Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration  Food and Drug Administration (FDA) Proposed
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Exculpatory Language in Informed Consent  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials  Food and Drug Administration (FDA) Proposed
Office Based Opioid Use Disorder Treatment Billing  Centers for Medicare & Medicaid Services (CMS) Proposed
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