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Guidance Category * Select guidance category Drug Development Biologics Medical Devices Food Safety Cosmetics Tobacco Products Clinical Trials Manufacturing Quality Systems Regulatory Submissions Labeling Post-Market Surveillance Inspection Guidelines Compliance Risk Management Pharmacovigilance Combination Products Breakthrough Therapy Orphan Drugs Generic Drugs Biosimilars Digital Health Software as Medical Device In Vitro Diagnostics Import/Export

Regulatory Phase Select regulatory phase Pre-IND/IDE IND/IDE Application Phase I Clinical Trial Phase II Clinical Trial Phase III Clinical Trial NDA/BLA Submission 510(k) Submission PMA Submission Pre-Market Review Post-Market Requirements Manufacturing Changes Labeling Updates Safety Reporting Inspection Preparation Compliance Issues Risk Evaluation Quality Agreement Facility Registration Product Registration Import/Export Requirements

Question Type * Select question type Interpretation of Requirements Compliance Clarification Submission Process Documentation Requirements Timeline Questions Technical Standards Safety Requirements Efficacy Standards Quality Specifications Labeling Requirements Risk Assessment Study Design Data Requirements Regulatory Strategy Pathway Selection Meeting Requests Inspection Preparation Enforcement Actions Policy Interpretation Best Practices

Product Type Select product type Prescription Drug Over-the-Counter Drug Biologic Biosimilar Vaccine Blood Product Gene Therapy Cell Therapy Medical Device (Class I) Medical Device (Class II) Medical Device (Class III) In Vitro Diagnostic Software as Medical Device Combination Product Dietary Supplement Food Additive GRAS Substance Cosmetic Tobacco Product Animal Drug Other Product Type

Urgency Level Select urgency level Immediate (Submission Due Soon) High (Within 2 Weeks) Medium (Within 1 Month) Low (Planning/Research) Compliance Issue Inspection Response Safety Concern Regulatory Meeting Prep Strategic Planning Routine Inquiry

Company Type Select company type Pharmaceutical Company Biotechnology Company Medical Device Company Contract Research Organization Contract Manufacturing Organization Academic Institution Government Agency Consulting Firm Law Firm Startup Company Small Business Large Corporation Non-Profit Organization International Company Individual Researcher

Response Format * Select response format Detailed Analysis Executive Summary Step-by-Step Guide Regulatory Checklist Q&A Format Compliance Roadmap Risk Assessment Best Practices Summary Regulatory Timeline Documentation Template Meeting Preparation Guide Submission Strategy Technical Interpretation Policy Summary Action Items List