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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Submitting Marketing Applications According to the ICH/CTD Format: General Considerations 2001  Food and Drug Administration (FDA) Proposed
Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VIII New Protein Consultations  Food and Drug Administration (FDA) Proposed
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes Guidance for Industry   Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VII Biotechnology Final Consultations  Food and Drug Administration (FDA) Proposed
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry  Food and Drug Administration (FDA) Proposed
1993 Draft Redbook II  Food and Drug Administration (FDA) Proposed
Notice of Proposed Rulemaking (NPRM) on Designation Renewal System Changes  Administration for Children and Families (ACF) Proposed
2020 Secretarial Determination to Lower Head Start Center-based Service Duration Requirement  Administration for Children and Families (ACF) Proposed
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