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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
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Supplemental Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration  Food and Drug Administration (FDA) Proposed
Survey Methodologies to Assess REMS Goals That Relate to Knowledge  Food and Drug Administration (FDA) Proposed
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations  Food and Drug Administration (FDA) Proposed
Treatment for Heart Failure: Endpoints for Drug Development Guidance for Industry  Food and Drug Administration (FDA) Proposed
Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control Guidance for Industry  Food and Drug Administration (FDA) Proposed
Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software Guidance for Industry  Food and Drug Administration (FDA) Proposed
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