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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Hypertension: Conducting Studies of Drugs to Treat Patients on a Background of Multiple Antihypertensive Drugs Guidance for Industry  Food and Drug Administration (FDA) Proposed
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Product Identifiers under the Drug Supply Chain Security Act - Questions and Answers  Food and Drug Administration (FDA) Proposed
Rare Diseases: Common Issues in Drug Development Guidance for Industry  Food and Drug Administration (FDA) Proposed
Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products  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
Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues Guidance for Industry: Draft Clinical/Medical  Food and Drug Administration (FDA) Proposed
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Inclusion of Older Adults in Cancer Clinical Trials: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 49441 documents.

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