Guidances directory

All guidance documents2,828 total

• 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• Complementary and Alternative Medicine Products and their Regulation by the Food and Drug Administration: Draft Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research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
• Using Electronic Means to Distribute Certain Product Information: Guidance for IndustryGuidance Document · Office of the Commissioner,Office of Policy, Legislation, and International Affairs,Office of Policy
• Draft Guidance for Industry and FDA Staff: Whole Grain Label StatementsGuidance Document · Human Foods Program
• Reports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997Guidance Document · Center for Drug Evaluation and Research
• Nonclinical Safety Evaluation of Pediatric Drug ProductsGuidance Document · Center for Drug Evaluation and Research
• Pharmacogenetic Tests and Genetic Tests for Heritable Markers: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Considerations for Developmental Toxicity Studies for Preventive and Therapeutic Vaccines for Infectious Disease Indications: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Providing Regulatory Submissions in Electronic Format Orphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions: Draft Draft Guidance for IndustryGuidance Document · Office of the Commissioner
• Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and FormatGuidance Document · Center for Drug Evaluation and Research
• Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
• Exploratory IND Studies: Guidance for Industry, Investigators, and ReviewersGuidance Document · Center for Drug Evaluation and Research
• Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMPGuidance Document · Center for Drug Evaluation and Research
• CVM GFI #166 (VICH GL38) Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP’s) - Phase IIGuidance Document · Center for Veterinary Medicine
• Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Laser Notice 54): Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #123 Development of Data Supporting Approval of NSAIDS for Use in AnimalsGuidance Document · Center for Veterinary Medicine
• Recommended Approaches to Integration of Genetic Toxicology Study ResultsGuidance Document · Center for Drug Evaluation and Research
• Redbook 2000: IV.C.6. Carcinogenicity Studies with RodentsGuidance Document · Human Foods Program
• Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
• Frequently Asked Questions About Medical Devices: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
• FDA Institutional Review Board Inspections: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner
• CPG Sec 515.775 Cocoa Powder, Press Cake - Adulteration with Insect and Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
• CPG Sec 540.650 Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked (Revised)Compliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 570.700 Mixed Nuts - Misbranding Involving Food StandardsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 565.100 FDA Jurisdiction Over Meat and Poultry ProductsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• CPG Sec 540.500 Tuna, Sable, Salmon, Shad-Smoked Cured, Adulteration Involving Food Additives, Sodium NitriteCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 562.550 Safety and Labeling of Waxed (Coated) Fruits and VegetablesCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
• CPG Sec 540.420 Raw Breaded Shrimp - Microbiological Criteria for Evaluating Compliance with Current Good Manufacturing Practice RegulationsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program