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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
EDPPPS Proposed Edits Tool V1 - December 2011 Centers for Medicare & Medicaid Services (CMS) Proposed
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Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VII Biotechnology Final Consultations Food and Drug Administration (FDA) Proposed
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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry Food and Drug Administration (FDA) Proposed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
Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 38791 documents.

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