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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (Edition 2)  Food and Drug Administration (FDA) Proposed
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How to Exchange Product Tracing Information  Food and Drug Administration (FDA) Proposed
Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry  Food and Drug Administration (FDA) Proposed
Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation  Food and Drug Administration (FDA) Proposed
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
Draft Instructions for Completing the Prescription Drug Plan Bid Pricing Tools for CY2023  Centers for Medicare & Medicaid Services (CMS) 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
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