Guidances directory

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All guidance documents2,854 total

CPG Sec 580100 Food Storage and Warehousing-Adulteration-Filth (Domestic and Import)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 570350 Peanuts, Shelled and Unshelled - Adulteration with Filth and Reject NutsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 527100 Butter - Adulteration Involving Insufficient Fat ContentCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 525375 Whole Ginger - Adulteration with Insect Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 578.500 Dimethylnitrosamine (DMNA) in Barley MaltCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 540.410 Shrimp - Frozen, Raw, Breaded or Lightly Breaded, Misbranding Involving Non-Compliance with StandardsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 540.250 Clams, Mussels, Oysters, Fresh, Frozen or Canned - Paralytic Shellfish PoisonCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 540.200 Chubs, Hot Process Smoked with Added Nitrite - Adulteration Involving Food Additives, Sodium NitriteCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec. 160.100 Regulatory Actions and Small BusinessCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 530.500 Wheat Germ Containing Non-Wheat Germ TissueCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 527.400 Whole Milk, Lowfat Milk, Skim Milk - Aflatoxin M1Compliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 527.350 Eggnog; Egg Nog Flavored Milk - Common or Usual NamesCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 527.250 Cheese & Cheese Products - Misbranding Involving Net ContentsCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 525.800 Tomato Sauce or Tomato Hot Sauce LabelingCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 525.575 Prepared Mustard - CompositionCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 550.650 Peaches, Canned, Frozen - Adulteration Due to Insects and MoldCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 550.605 Olives Stuffed with Minced Pimentos - LabelingCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 585.750 Sauerkraut - Definition; Adulteration by ThripsCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 525.100 Whole & Ground Allspice - Adulteration by Mold; Insect & Rodent FilthCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 520.300 Acidified Low-Acid Canned Foods - Adulteration Due to High pHCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 585.500 Mushrooms, Canned or Dried (Freeze-Dried or Dehydrated) - Adulteration Involving Maggots, Mites, DecompositionCompliance Policy Guide (CPG) · Office of Inspections and Investigations Human Foods Program
CPG Sec 550.475 Jellies, NonstandardizedCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 585.325 Corn on the Cob, Canned - Quantity of Contents DeclarationCompliance Policy Guide (CPG) · Human Foods Program Office of Inspections and Investigations
CPG Sec 585890 Tomato Products - Adulteration with Drosophila Fly Eggs and MaggotsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 585875 Tomatoes - Canned - Misbranding Involving Food Standards (Peel)Compliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 585900 Tomato Products - Adulteration with MoldCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CVM GFI #135 Validation of Analytical Procedures for Type C Medicated FeedsGuidance Document · Center for Veterinary Medicine
Applicability of the Performance Standard for High-Intensity Mercury Vapor Discharge Lamps (21 CFR 104030)Guidance Document · Center for Devices and Radiological Health
Guidance for Industry: Notice to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport VehiclesGuidance Document · Human Foods Program
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human PharmaceuticalsGuidance Document · Center for Drug Evaluation and Research
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic DrugsGuidance Document · Center for Drug Evaluation and Research
Letter to State Regulatory Agencies and Firms That Produce Treated (but not Pasteurized) and Untreated Juice and CiderIndustry Letter · Human Foods Program
Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Assays: Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
How to Comply with the Pediatric Research Equity ActGuidance Document · Center for Drug Evaluation and Research
M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug DictionariesGuidance Document · Center for Drug Evaluation and Research
Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy VolunteersCenter for Drug Evaluation and Research
Menstrual Tampons and Pads: Information for Premarket Notification Submissions (510(k)s) - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Nonclinical Pharmacology/Toxicology Development of Topical Drugs Intended to Prevent the Transmission of Sexually Transmitted Diseases (STD) and/or for the Development of Drugs Intended to Act as Vaginal ContraceptivesCenter for Drug Evaluation and Research
Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing ProcessGuidance Document · Center for Drug Evaluation and Research
Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Nonclinical Studies for the Safety Evaluation of Pharmaceutical ExcipientsGuidance Document · Center for Drug Evaluation and Research
CPG Sec 315100 Illegal Interstate Commercial Shipment of Dentures (CPG retitled and revised 5/19/2005)Compliance Policy Guide (CPG) · Office of Regulatory Affairs
Guidance for Industry: Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk ConsiderationsGuidance Document · Human Foods Program
CPG Sec 560400 Imported Milk and Cream - Federal Import Milk ActCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 555425 Foods, Adulteration Involving hard or Sharp Foreign ObjectsCompliance Policy Guide (CPG) · Office of Inspections and Investigations
CPG Sec 525225 - Whole Cassia or Whole Cinnamon, Ground Cinnamon - Adulteration by Insect and Rodent Filth; Mold; Mammalian ExcretaCompliance Policy Guide (CPG) · Office of Inspections and Investigations
Evaluating the Risks of Drug Exposure in Human PregnanciesGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 100.700 GWQAP Pre-Award Evaluation - Inadequate Information to Evaluate Prospective SupplierCompliance Policy Guide (CPG) · Office of Regulatory Affairs
Providing Regulatory Submissions in Electronic Format — Content of LabelingGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Templates for Reporting Toxicology DataGuidance Document · Human Foods Program
Guidance for Industry: Submitting Requests under 21 CFR 170.39 Threshold of Regulation for Substances Used in Food-Contact ArticlesGuidance Document · Human Foods Program
CPG Sec. 390.300 Assessment of Civil Penalties Against Manufacturers and Importers of Electronic ProductsGuidance Document · Office of Regulatory Affairs
Guidance for Industry: Pre-Petition Consultations for Food Additives and Color AdditivesGuidance Document · Human Foods Program
E2E Pharmacovigilance PlanningGuidance Document · Center for Drug Evaluation and Research
Guidance for Review Staff and Industry Good Review Management Principles and Practices for PDUFA ProductsGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Dietary Supplement Labeling GuideGuidance Document · Human Foods Program
Premarketing Risk Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Development and Use of Risk Minimization Action Plans: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CPG Sec 300500 *Reprocessing of Single Use* DevicesCompliance Policy Guide (CPG) · Office of Regulatory Affairs
E2B(M) Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a)Compliance Policy Guide (CPG) · Center for Devices and Radiological Health Office of Regulatory Affairs
Pharmacogenomic Data Submissions; Examples of Voluntary Submissions or Submissions Required Under 21 CFR 312, 314, or 601Guidance Document · Center for Drug Evaluation and Research
Pharmacogenomic Data Submissions: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 398.700 Reloaders of X-ray Tube Housing Assemblies; Applicability of Medical Device Establishment Registration, Device Listing and Biennial InspectionGuidance Document · Office of Regulatory Affairs
CPG Sec. 398.325 Regulatory Actions Against Assemblers Noncompliant Diagnostic X-Ray EquipmentGuidance Document · Office of Regulatory Affairs
CPG Sec. 398.100 Definition of General Purpose Radiographic X-Ray System - 21 CFR 1020.30(b)Compliance Policy Guide (CPG) · Office of Regulatory Affairs Center for Devices and Radiological Health
CPG Sec. 396.300 Defective Suntanning Booths and BedGuidance Document · Office of Regulatory Affairs
CPG Sec 310210 Blood Pressure Measurement Devices (Sphygmomanometers) - AccuracyCompliance Policy Guide (CPG) · Office of Regulatory Affairs
CVM GFI #173 Appendix for the Animal Drug Sponsor Fees Under ADUFAGuidance Document · Center for Veterinary Medicine
CVM GFI #173 Animal Drug Sponsor Fees Under the Animal Drug User Fee Act (ADUFA)Guidance Document · Center for Veterinary Medicine
Gingivitis: Development and Evaluation of Drugs for Treatment or PreventionGuidance Document · Center for Drug Evaluation and Research
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software: Guidance for IndustryGuidance Document · Center for Devices and Radiological Health
Guidance for Industry: Labeling for Cosmetics Containing Alpha Hydroxy AcidsGuidance Document · Office of the Commissioner,Office of the Chief Scientist
Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
M4: The CTD -- General Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Clinical Data Presentations for Orthopedic Device Applications - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
M4: The CTD -- Efficacy Questions and AnswersGuidance Document · Center for Drug Evaluation and Research
Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
CVM GFI #122 Manufacture and Labeling of Raw Meat Foods for Companion and Captive Noncompanion Carnivores and OmnivoresGuidance Document · Center for Veterinary Medicine
CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records RetentionCompliance Policy Guide (CPG) · Office of Regulatory Affairs
Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps): Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Pharmacokinetics in Pregnancy — Study Design, Data Analysis, and Impact on Dosing and LabelingGuidance Document · Center for Drug Evaluation and Research
Clinical Trial Considerations: Vertebral Augmentation Devices to Treat Spinal Insufficiency Fractures - Guidance for Industry and FDA StaffGuidance Document · Center for Devices and Radiological Health
Use of Nucleic Acid Tests on Pooled and Individual Samples from Donors of Whole Blood and Blood Components (including Source Plasma and Source Leukocytes) to Adequately and Appropriately Reduce the Risk of Transmission of of HIV-1 and HCV: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance: Guidance for IndustryGuidance Document · Center for Drug Evaluation and Research
Guidance for Industry: Recommendations to Processors of Apple Juice or Cider on the Use of Ozone for Pathogen Reduction PurposesGuidance Document · Human Foods Program
FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for IndustryGuidance Document · Center for Biologics Evaluation and Research
Class II Special Controls Guidance Document: Serological Assays for the Detection of Beta-Glucan (PDF version)Special Controls Document · Center for Devices and Radiological Health
The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical InvestigatorsGuidance Document · Center for Drug Evaluation and Research
Independent Consultants for Biotechnology Clinical Trial Protocols: Guidance for IndustryGuidance Document · Office of the Commissioner
Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug ApplicationGuidance Document · Center for Drug Evaluation and Research
Developing Medical Imaging Drug and Biological Products Part 1: Conducting Safety AssessmentsGuidance Document · Center for Drug Evaluation and Research
Developing Medical Imaging Drug and Biological Products Part 3: Design, Analysis, and Interpretation of Clinical StudiesGuidance Document · Center for Drug Evaluation and Research
Developing Medical Imaging Drug and Biological Products Part 2: Clinical IndicationsGuidance Document · Center for Drug Evaluation and Research
CPG Sec. 690.300 Canned Pet Food (Withdrawn 4/30/2019)Compliance Policy Guide (CPG) · Center for Veterinary Medicine Office of Regulatory Affairs
M4: The CTD -- Quality Questions and Answers /Location IssuesGuidance Document · Center for Drug Evaluation and Research
Q1E Evaluation of Stability DataGuidance Document · Center for Drug Evaluation and Research