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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Bioavailability Studies Submitted in NDAs or INDs – General Considerations  Food and Drug Administration (FDA) Proposed
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry  Food and Drug Administration (FDA) Proposed
Notice of Proposed Rulemaking (NPRM) on Designation Renewal System Changes  Administration for Children and Families (ACF) Proposed
Clinical Lactation Studies: Considerations for Study Design   Food and Drug Administration (FDA) Proposed
Coronary Drug-Eluting Stents-Nonclinical and Clinical Studies  Food and Drug Administration (FDA) Proposed
Coronary Drug-Eluting Stents — Nonclinical and Clinical Studies -Companion Document  Food and Drug Administration (FDA) Proposed
Clinical Lactation Studies--Study Design, Data Analysis, and Recommendations for Labeling  Food and Drug Administration (FDA) Proposed
Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products  Food and Drug Administration (FDA) Proposed
Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
2020 Secretarial Determination to Lower Head Start Center-based Service Duration Requirement  Administration for Children and Families (ACF) Proposed
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