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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Statistical Aspects of the Design, Analysis, and Interpretation of Chronic Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Proposed
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999  Food and Drug Administration (FDA) Proposed
Submission of Quality Metrics Data Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submitting Debarment Certification Statements  Food and Drug Administration (FDA) Proposed
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations  Food and Drug Administration (FDA) Proposed
SUPAC: Manufacturing Equipment Addendum  Food and Drug Administration (FDA) Proposed
Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration  Food and Drug Administration (FDA) Proposed
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