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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Draft Guidance for Industry: Voluntary Labeling Indicating Whether Food Has or Has Not Been Derived From Genetically Engineered Atlantic Salmon  Food and Drug Administration (FDA) Proposed
Drug Abuse and Dependence Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Drug Master Files Guidance for Industry  Food and Drug Administration (FDA) Proposed
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry  Food and Drug Administration (FDA) Proposed
DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers  Food and Drug Administration (FDA) Proposed
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information  Food and Drug Administration (FDA) Proposed
E12A Principles for Clinical Evaluation of New Antihypertensive Drugs  Food and Drug Administration (FDA) Proposed
E19 OPTIMISATION OF SAFETY DATA COLLECTION  Food and Drug Administration (FDA) Proposed
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES  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
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