Guidances directory

All guidance documents2,320 total

• Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• E15 Pharmacogenomics Definitions and Sample CodingGuidance Document · Center for Drug Evaluation and Research
• Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs): Guidance for FDA Reviewers and SponsorsGuidance Document · Center for Biologics Evaluation and Research
• CPG Sec 500500 Guidance Levels for 3-MCPD (3-chloro-1,2-propanediol) in Acid-Hydrolyzed Protein and Asian-Style SaucesCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Q4B Annex I: Residue on Ignition/Sulphated Ash General ChapterGuidance Document · Center for Drug Evaluation and Research
• Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation RegionsGuidance Document · Center for Drug Evaluation and Research
• Coronary and Carotid Embolic Protection Devices - Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• Medical Glove Guidance Manual: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #179 Use of Animal Clones and Clone Progeny for Human Food and Animal FeedGuidance Document · Center for Veterinary Medicine
• The Review and Inspection of Premarket Approval Application Manufacturing Information and Operations: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• CPG Sec 575100 Draft Revision - Pesticide Chemical Residues in Food - Enforcement CriteriaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
• Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review StaffGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug SubstancesGuidance Document · Center for Veterinary Medicine
• Adequate and Appropriate Donor Screening Tests for Hepatitis B; Hepatitis B Surface Antigen (HBsAg) Assays Used to Test Donors of Whole Blood and Blood Components, Including Source Plasma and Source Leukocytes: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• CVM GFI #93 (VICH GL11(R)) Impurities in New Veterinary Medicinal ProductsGuidance Document · Center for Veterinary Medicine
• CVM GFI #73 (VICH GL3(R)) Stability Testing of New Veterinary Drug Substances and Medicinal ProductsGuidance Document · Center for Veterinary Medicine
• Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
• Role of HIV Drug Resistance Testing in Antiretroviral Drug DevelopmentGuidance Document · Center for Drug Evaluation and Research
• Biological Indicator (BI) Premarket Notification [510(k)] Submissions : Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
• CVM GFI #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease ClaimsGuidance Document · Center for Veterinary Medicine
• 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
• 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
• 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
• 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
• 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
• User Fee Waivers for FDC and Co-Packaged HIV Drugs for PEPFARGuidance Document · Center for Drug Evaluation and Research
• 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
• 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
• 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
• 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
• 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
• CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls DocumentationGuidance Document · Center for Veterinary Medicine
• 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
• 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
• 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
• Significant Risk and Nonsignificant Risk Medical Device Studies: Guidance For IRBs, Clinical Investigators, and SponsorsInformation Sheet · Office of the Commissioner