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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
ANDA Submissions – Amendments and Requests for Final Approval to Tentatively Approved ANDAs  Food and Drug Administration (FDA) Proposed
Bioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)  Food and Drug Administration (FDA) Proposed
CVM GFI #264 Standardized Medicated Feed Assay Limits  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government  Food and Drug Administration (FDA) Proposed
E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES  Food and Drug Administration (FDA) Proposed
Format and Content of a REMS Document Guidance for Industry  Food and Drug Administration (FDA) Proposed
Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
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