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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products  Food and Drug Administration (FDA) Proposed
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry  Food and Drug Administration (FDA) Proposed
Nonproprietary Naming of Biological Products: Update Guidance for Industry  Food and Drug Administration (FDA) Proposed
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Major Depressive Disorder: Developing Drugs for Treatment  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M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries  Food and Drug Administration (FDA) Proposed
M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
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