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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part I Introduction  Food and Drug Administration (FDA) Proposed
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials  Food and Drug Administration (FDA) Proposed
Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics  Food and Drug Administration (FDA) Proposed
Identifying Trading Partners Under the Drug Supply Chain Security Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes  Food and Drug Administration (FDA) Proposed
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act  Food and Drug Administration (FDA) Proposed
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