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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Nonmetastatic, Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials  Food and Drug Administration (FDA) Proposed
Pre-Launch Activities Importation Requests (PLAIR)  Food and Drug Administration (FDA) Proposed
Qualification Process for Drug Development Tools Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Safety Assessment for IND Safety Reporting Guidance for Industry  Food and Drug Administration (FDA) Proposed
Transdermal and Topical Delivery Systems - Product Development and Quality Considerations  Food and Drug Administration (FDA) Proposed
How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products-Content and Format: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Principles of Premarket Pathways for Combination Products: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation - Non-clinical Testing and Clinical Considerations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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