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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
M9 Biopharmaceutics Classification System-Based Biowaivers  Food and Drug Administration (FDA) Proposed
Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers  Food and Drug Administration (FDA) Proposed
Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry  Food and Drug Administration (FDA) Proposed
Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings : Draft Guidance for Industry   Food and Drug Administration (FDA) Proposed
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