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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
E7 Studies in Support of Special Populations: Geriatrics  Food and Drug Administration (FDA) Final
E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers  Food and Drug Administration (FDA) Final
E8 General Considerations for Clinical Trials  Food and Drug Administration (FDA) Final
E9 Statistical Principles for Clinical Trials  Food and Drug Administration (FDA) Final
Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry  Food and Drug Administration (FDA) Final
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff  Food and Drug Administration (FDA) Final
eCTD TECHNICAL CONFORMANCE GUIDE  Food and Drug Administration (FDA) Final
Effective Visual Control of Laser Projections (Laser Notice 47)  Food and Drug Administration (FDA) Final
Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications — Questions and Answers  Food and Drug Administration (FDA) Final
Electrocardiograph (ECG) Lead Switching Adapter  Food and Drug Administration (FDA) Final
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