Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products
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Humanitarian Use Device (HUD) Designations guidance document is intended to assist applicants in the preparation and submission of Humanitarian Use Device (HUD) designation requests…
Read more →Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry document provides guidance to sponsors and applicants submitting investigational new drug applications (INDs),…
Read more →Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry
Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications Guidance for Industry guidance describes…
Read more →Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry
Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry guidance recommends approaches that sponsors of…
Read more →Certificates of Confidentiality Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff
Certificates of Confidentiality Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff guidance describes FDA implementation of the revised provisions applicable…
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