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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Product Title and Initial U.S. Approval in the Highlights of Prescribing Information for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers  Food and Drug Administration (FDA) Proposed
Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method  Food and Drug Administration (FDA) Proposed
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products  Food and Drug Administration (FDA) Proposed
Q3C: Appendix 4  Food and Drug Administration (FDA) Proposed
Q1B Photostability Testing of New Drug Substances and Products  Food and Drug Administration (FDA) Proposed
Postapproval Changes to Drug Substances Guidance for Industry  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Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration  Food and Drug Administration (FDA) Proposed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
This Guidance Portal contains 28730 documents.

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