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HHS Guidance Submissions

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S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies  Food and Drug Administration (FDA) Final
Sample WHO Certificate for Quality of a Pharmaceutical Product  Food and Drug Administration (FDA) Final
Small Entity Compliance Guide: Mitigation Strategies to Protect Food Against Intentional Adulteration  Food and Drug Administration (FDA) Final
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency   Food and Drug Administration (FDA) Final
Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry  Food and Drug Administration (FDA) Final
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products — Content and Format  Food and Drug Administration (FDA) Final
Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations  Food and Drug Administration (FDA) Proposed
Cancer Clinical Trial Eligibility Criteria: Minimum Age for Pediatric Patients  Food and Drug Administration (FDA) Proposed
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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