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Title OpDiv/StaffDiv Guidance Status Sort descending Issue Date
Draft Guidance for Industry: Regulatory Submissions to OFAS, Part VI GRAS Notices  Food and Drug Administration (FDA) Proposed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Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: The Use of an Alternate Name for Potassium Chloride in Food Labeling  Food and Drug Administration (FDA) Proposed
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation  Food and Drug Administration (FDA) Proposed
Good ANDA Submission Practices Guidance for Industry  Food and Drug Administration (FDA) Proposed
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