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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
Specification of the Unique Facility Identifier (UFI) System for Drug Establishment  Food and Drug Administration (FDA) Final
Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments  Food and Drug Administration (FDA) Final
Statistical Approaches to Establishing Bioequivalence  Food and Drug Administration (FDA) Final
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Street Drug Alternatives  Food and Drug Administration (FDA) Final
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Study of Drugs Likely to be used in the Elderly  Food and Drug Administration (FDA) Final
Submission of Abbreviated Reports and Synopses in Support of Marketing Applications.  Food and Drug Administration (FDA) Final
Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revised)  Food and Drug Administration (FDA) Final
Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications  Food and Drug Administration (FDA) Final
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