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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort ascending Issue Date
Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans  Food and Drug Administration (FDA) Proposed
Pharmacogenomic Data Submissions — Companion Guidance  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and Labeling  Food and Drug Administration (FDA) Proposed
Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products  Food and Drug Administration (FDA) Proposed
Population Pharmacokinetics  Food and Drug Administration (FDA) Proposed
Postapproval Pregnancy Safety Studies Guidance for Industry   Food and Drug Administration (FDA) Proposed
Pre-Launch Activities Importation Requests (PLAIR)  Food and Drug Administration (FDA) Proposed
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials  Food and Drug Administration (FDA) Proposed
Presenting Risk Information in Prescription Drug and Medical Device Promotion  Food and Drug Administration (FDA) Proposed
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