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HHS Guidance Documents
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Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1): Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently…  Food and Drug Administration (FDA) Proposed
Q3D(R2) – Guideline for Elemental Impurities: International Council for Harmonisation; Draft Guidance for Industry  Food and Drug Administration (FDA) Final
S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals : International Council for Harmonisation; Draft Guidance for Industry  Food and Drug Administration (FDA) Final
Letter - Manufacturers, Distributors and Importers of Condom Products (included in Condom Packet 398) : Letter - Manufacturers, Distributors and Importers of Condom Products  Food and Drug Administration (FDA) Final
Recommendations for Donor Screening with a Licensed Test for HIV-1 Antigen: Memorandum to All Registered Blood Establishments  Food and Drug Administration (FDA) Final
Revised Recommendations for Red Blood Cell Immunization Programs for Source Plasma Donors: Memorandum to Licensed Establishments  Food and Drug Administration (FDA) Final
Additional Recommendations for Donor Screening With a Licensed Test for HIV-1 Antigen: Memorandum to Registered Blood and Plasma Establishments  Food and Drug Administration (FDA) Final
Additional Recommendations for Testing Whole Blood, Blood Components, Source Plasma and Source Leukocytes for Antibody to Hepatitis C Virus Encoded Antigen (Anti-HCV): Memorandum to Registered Blood and Plasma Establishments  Food and Drug Administration (FDA) Final
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3): Draft New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3).”  Food and Drug Administration (FDA) Proposed
PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline  Food and Drug Administration (FDA) Final
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