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HHS Guidance Submissions

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Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved Application: Biological Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for Industry  Food and Drug Administration (FDA) Final
Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications: Guidance for Industry  Food and Drug Administration (FDA) Final
Charging for Investigational Drugs Under an IND - Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs): Guidance for Industry  Food and Drug Administration (FDA) Final
Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection: Guidance for Industry  Food and Drug Administration (FDA) Final
Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry  Food and Drug Administration (FDA) Final
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