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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 4  Food and Drug Administration (FDA) Proposed
Rheumatoid Arthritis: Developing Drug Products for Treatment  Food and Drug Administration (FDA) Proposed
SUPAC: Manufacturing Equipment Addendum  Food and Drug Administration (FDA) Proposed
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Pediatric Study Plans for Oncology Drugs: Transitional Information Until Full Implementation of FDARA Section 504 Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Substantial Equivalence Reports: Manufacturer Requests for Extensions or to Change the Predicate Tobacco Product: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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