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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Cancer Clinical Trial Eligibility Criteria: Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections  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
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality  Food and Drug Administration (FDA) Proposed
Certification Process of Designated Medical Gases  Food and Drug Administration (FDA) Proposed
CGO Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli  Food and Drug Administration (FDA) Proposed
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 50173 documents.

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