Guidances directory

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All guidance documents2,854 total

Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, Processors, and TransportersGuidance Document · Human Foods Program
Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Laser Notice 55)Guidance Document · Center for Devices and Radiological Health
Compliance Guide for Cabinet X-Ray SystemsGuidance Document · Center for Devices and Radiological Health
Non-clinical Information for Femoral Stem Prostheses: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry and FDA: Dear Manufacturer Letter Regarding Sugar Free ClaimsIndustry Letter · Human Foods Program
Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Pharmacogenomic Data Submissions — Companion GuidanceGuidance Document · Center for Drug Evaluation and Research
Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs): Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
ANDAs:Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry and Other Stakeholders: Redbook 2000 : Toxicological Principles for the Safety Assessment of Food IngredientsGuidance Document · Human Foods Program
Redbook 2000: IV.C.8. In-Utero Exposure Phase for Addition to Carcinogenicity Studies or Chronic Toxicity Studies with RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.7. Combined Chronic Toxicity/Carcinogenicity Studies with RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.5.a. Chronic Toxicity Studies with RodentsGuidance Document · Human Foods Program
Redbook 2000: IV.C.1. Short-Term Tests for Genetic ToxicityGuidance Document · Human Foods Program
Redbook 2000: III Recommended Toxicity StudiesInformation Sheet · Human Foods Program
Redbook 2000: I IntroductionGuidance Document · Human Foods Program
Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
Bundling Multiple Devices or Multiple Indications in a Single Submission: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Pre-Clinical and Clinical Studies for Neurothrombectomy Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Refrigerated Carrot Juice and Other Refrigerated Low-Acid JuicesGuidance Document · Human Foods Program
Redbook 2000: IV.B.4. Statistical Considerations in Toxicity StudiesGuidance Document · Human Foods Program
CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and InspectionsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Informed Consent Recommendations for Source Plasma Donors Participating in Plasmapheresis and Immunization Programs: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADA/ANADAGuidance Document · Center for Veterinary Medicine
CVM GFI #137 Analytical Methods Description for Type C Medicated FeedsGuidance Document · Center for Veterinary Medicine
Small Business Nutrition Labeling Exemption GuidanceGuidance Document · Human Foods Program
Dental Handpieces - Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #136 Protocols for the Conduct of Method Transfer Studies for Type C Medicated Feed Assay MethodsGuidance Document · Center for Veterinary Medicine
CVM GFI #150 Concerns Related to the use of Clove Oil as an Anesthetic for FishGuidance Document · Center for Veterinary Medicine
Approval of Alternate Means of Labeling for Laser Products (Laser Notice 53)Guidance Document · Center for Devices and Radiological Health
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #183 Animal Drug User Fees: Fees Exceed Costs Waiver/ReductionGuidance Document · Center for Veterinary Medicine
Orally Inhaled and Intranasal Corticosteroids: Evaluation of the Effects on Growth in ChildrenGuidance Document · Center for Drug Evaluation and Research
Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Guidance for Industry and FDA: Letter to Industry, State and Local Food Regulators and Inspectors Regarding Web-based ALERT TrainingIndustry Letter · Human Foods Program
User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFARGuidance Document · Center for Drug Evaluation and Research
CPG Sec 540.600 Fish, Shellfish, Crustaceans and other Aquatic Animals - Fresh, Frozen or Processed - Methyl MercuryCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
Guidance for Industry and FDA: Dear Manufacturer Letter Regarding Food LabelingIndustry Letter · Human Foods Program
Process for Handling Referrals to FDA Under 21 CFR 5054 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and SponsorsGuidance Document · Office of the Commissioner
Guidance for Industry: Lead in Candy Likely To Be Consumed Frequently by Small Children: Recommended Maximum Level and Enforcement PolicyGuidance Document · Human Foods Program
Decorative, Non-corrective Contact Lenses: Guidance for Industry, FDA Staff, Eye Care Professionals, and ConsumersGuidance Document · Center for Devices and Radiological Health
Prescription Drug Marketing Act (PDMA) Requirements- Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
CVM GFI #35 Bioequivalence GuidanceGuidance Document · Center for Veterinary Medicine
Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood ComponentsGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and DevicesCompliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Inspections and Investigations
Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice RegulationsGuidance Document · Center for Drug Evaluation and Research
Public Availability of Labeling Changes in "Changes Being Effected" SupplementsGuidance Document · Center for Drug Evaluation and Research
Keratome and Replacement Keratome Blades Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Compliance with 21 CFR Part 1271150(c)(1) – Manufacturing Arrangements: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA StaffGuidance Document · Office of the Commissioner
Implementing a Collection Program for Source Plasma Containing Disease-Associated and Other Immunoglobulin (IgG) Antibodies: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Q3B(R) Impurities in New Drug Products (Revision 3)Guidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Estimating Dietary Intake of Substances in FoodGuidance Document · Human Foods Program
CVM GFI #141 (VICH GL28) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity TestingGuidance Document · Center for Veterinary Medicine
CVM GFI #147 (VICH GL31) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90 Day) Toxicity TestingGuidance Document · Center for Veterinary Medicine
CVM GFI #148 (VICH GL32) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity TestingGuidance Document · Center for Veterinary Medicine
CVM GFI #160 (VICH GL37) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity TestingGuidance Document · Center for Veterinary Medicine
Useful Written Consumer Medication Information (CMI)Guidance Document · Center for Drug Evaluation and Research
CPG Sec. 608.100 Human-Labeled Drugs Distributed and Used in Animal Medicine (Withdrawn 7/7/2006)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
CPG Sec. 616.100 Streptomycin Residues in Cattle Tissues (Withdrawn 7/7/2006)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
Guidance for Industry: Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food UseGuidance Document · Human Foods Program
CVM GFI #176 (VICH GL39) Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical SubstancesGuidance Document · Center for Veterinary Medicine
CVM GFI #177 (VICH GL40) Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal ProductsGuidance Document · Center for Veterinary Medicine
Antiviral Product Development--Conducting and Submitting Virology Studies to the AgencyGuidance Document · Center for Drug Evaluation and Research
Chronic Cutaneous Ulcer and Burn Wounds -- Developing Products for TreatmentGuidance Document · Center for Drug Evaluation and Research
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HBV Resistance DataGuidance Document · Center for Drug Evaluation and Research
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HCV Resistance DataGuidance Document · Center for Drug Evaluation and Research
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency : Guidance for Submitting Influenza Resistance DataGuidance Document · Center for Drug Evaluation and Research
Antiviral Product Development--Conducting and Submitting Virology Studies to the Agency: Guidance for Submitting HIV Resistance DataGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Summary Table of Recommended Toxicological Testing for Additives Used in FoodGuidance Document · Human Foods Program
CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls DocumentationGuidance Document · Center for Veterinary Medicine
Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Attachment 2Guidance Document · Human Foods Program
Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN - Attachment 1Guidance Document · Human Foods Program
Guidance for Industry: Appendix E of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (40 CFR 1508.27)Guidance Document · Human Foods Program
Guidance for Industry: Appendix D of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANGuidance Document · Human Foods Program
Guidance for Industry: Appendix C of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANGuidance Document · Human Foods Program
Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANGuidance Document · Human Foods Program
Guidance for Industry: FDA's Implementation of Qualified Health ClaimsGuidance Document · Human Foods Program
Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact LensesGuidance Document · Human Foods Program
Guidance for Industry: Appendix B for Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANGuidance Document · Human Foods Program
Guidance for Industry: Appendix A of Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSANGuidance Document · Human Foods Program
Compliance with Section 301 of the Medical Device User Fee and Modernization Act of 2002, as amended – Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's)Guidance Document · Center for Veterinary Medicine
Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable : Guidance for Sponsors, Institutional Review Boards, and Food and Drug Administration StaffGuidance Document · Center for Devices and Radiological Health
S8 Immunotoxicity Studies for Human PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
Redbook 2000: IV.C.1.c Mouse Lymphoma Thymidine Kinase Gene Mutation AssayGuidance Document · Human Foods Program
Establishment and Operation of Clinical Trial Data Monitoring Committees: Guidance for Clinical Trial SponsorsGuidance Document · Center for Biologics Evaluation and Research
Dental Curing Lights - Premarket Notification [510(k)]: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Tonometers - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for IndustryGuidance Document · Office of the Commissioner
Nonclinical Safety Evaluation of Drug or Biologic CombinationsGuidance Document · Center for Drug Evaluation and Research
Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free ClinicsGuidance Document · Center for Drug Evaluation and Research
Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Internal Radioactive Contamination —Development of Decorporation AgentsGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Frequently Asked Questions about FDA's Regulation of Infant FormulaGuidance Document · Human Foods Program