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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Child-Resistant Packaging Statements in Drug Product Labeling 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Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VII Biotechnology Final Consultations  Food and Drug Administration (FDA) Proposed
Solicitation of Information and Recommendations for Developing a Compliance Program Guidance for the Pharmaceutical Industry  Office of Inspector General (OIG) Proposed
Solicitation of New Safe Harbors and Special Fraud Alerts  Office of Inspector General (OIG) Proposed
Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards-Extension of Comment Period  Office of Inspector General (OIG) Proposed
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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #239 Human Food By-Products For Use As Animal Food  Food and Drug Administration (FDA) Proposed
Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices  Food and Drug Administration (FDA) Proposed
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