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HHS Guidance Submissions

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date Sort descending
Formatting, Assembling and Submitting New Drug and Antibiotic Applications*  Food and Drug Administration (FDA) Final
Summary for New Drug and Antibiotic Applications--Format and Content of the Summary for New Drug and Antibiotic Applications  Food and Drug Administration (FDA) Final
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application  Food and Drug Administration (FDA) Final
GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS  Food and Drug Administration (FDA) Final
All U.S. Condom Manufacturers, Importers and Repackagers  Food and Drug Administration (FDA) Final
CPG Sec. 425.300 Computerized Drug Processing; Source Code for Process Control Application Programs  Food and Drug Administration (FDA) Final
CPG Sec. 460.450 Status of Mail-Order Filling of Prescriptions  Food and Drug Administration (FDA) Final
CPG Sec. 450.400 Labeling and Distribution of OTC Drugs in Vending Machines  Food and Drug Administration (FDA) Final
CPG Sec. 430.300 Labeling Shipping Containers of Drugs  Food and Drug Administration (FDA) Final
CPG Sec. 454.100 OTC Ear Drop Preparations  Food and Drug Administration (FDA) Final
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