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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
ANDAs: Impurities in Drug Substances: Guidance for Industry  Food and Drug Administration (FDA) Final
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017 Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Availability of FDA’s eSubmitter Program for Regulatory Submissions from Licensed Blood Establishments: Guidance for Industry  Food and Drug Administration (FDA) Final
Availability of Licensed Donor Screening Tests Labeled for Use with Cadaveric Blood Specimens: Guidance for Industry  Food and Drug Administration (FDA) Final
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry  Food and Drug Administration (FDA) Final
BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry  Food and Drug Administration (FDA) Final
Blood Establishment Computer System Validation in the User's Facility: Guidance for Industry  Food and Drug Administration (FDA) Final
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